Some of these products whose exclusivity periods are about to expire and will soon face competition from biosimilars are listed in TABLE 2.23. Barren Space Productions. Unleashing the next wave of scientific innovations, Research and Business Development Partnerships. Reproduction in whole or in part without permission is prohibited. -IXIFI (PF-06438179, infliximab-qbtx), as a biosimilar to Remicade (infliximab) for all eligible indications of the reference product (US) -Steglatro (ertugliflozin) and Fixed-Dose Combinations Steglujan Even though they account for <1% of all prescriptions dispensed in the U.S., they constitute 28% of prescription-drug spending.1 The number of billable therapeutic biologics increased from 80 in 2013 to about 96 in 2014, including older medications such as collagenase that were approved as far back as 1965.2 It is expected that the biologics market will increase at a rate of more than 20% per year, and that by 2025 more than 70% of New Drug Approvals would be biological products.3 The increasing use of these products underlines the need for cost control, especially for those agents that have enjoyed a lengthy period of exclusive use. We invest in scientific and technical excellence to develop and launch a pipeline of new vaccines and specialty medicines across our four core . Polyarticular JIA in children aged 4 years. Express Scripts estimated that the U.S. could save $250 billion between 2014 and 2024 if 11 of the likeliest biosimilars reached the market.7 This article discusses the biosimilars that have been approved by the FDA as well as some that may obtain approval in the near future. While biosimilars mean savings for patients, pharmacists may need to facilitate the use of these products by engaging further with prescribers, insurance companies, and the FDA. The company reported second quarter 2021 sales of $14 million for these zones. 5 0 obj
We also have candidates in early-phase development in these therapy areas. White paper: an outlook on U.S. biosimilar competition. A clinicians guide to biosimilars in oncology. Pfizer has one of the most extensive biosimilars pipelines globally, with several molecules under development for the treatment of serious and chronic diseases. This site is intended only for U.S. healthcare professionals. Another potential new entrant in 2020, McNamara said, is the Pfizer/Hospira biosimilar HSP 130, which remains under FDA review. As with any new developments, there are likely to be some challenges, particularly since biosimilars, unlike generics, cannot be automatically substituted for branded products. Pfizer Pipeline Snapshot Pipeline represents progress of R&D programs as of May 4, 2021 17 programs advanced or are new 2 programs discontinued since last update Included are 68 NMEs, 31 additional indications, plus 0 biosimilar Discovery Projects Phase 1 29 Phase 2 38 Phase 3 22 Registration 10 Total 99 Snapshot as of Pfizer Pipeline May 4, 2021 1. That compares with 1 launch and 2 approvals in the year-ago quarter. 25 de maio de 2019. At the state level, we have focused our efforts on meaningful solutions to directly address patient affordability challenges. 2) Postmarketing data: Since the FDA approval process for biosimilars is accelerated, postmarketing data are vital for the safe and effective use of these products. Organon, the planned Merck biosimilars and womens health products spinoff slated to go public in June 2021, was featured in a presentation. Biological products have become a large part of healthcare delivery in the United States. Sandoz. Other serious adverse effects may include liver injury, blood problems, lupuslike syndrome, psoriasis, and, in rare cases, nervous system disorders.12, The product labeling for Inflectra includes a black box warning relating to the increased risk of serious infections that can lead to hospitalizations or death, including tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to other opportunistic infections. stream
Untangling biosimilars. Biologics are commonly used to treat autoimmune disorders, inflammatory diseases, and cancers. Inflectra is manufactured by Celltrion for Hospira.12 When contacted, Hospira stated that it was not able to release the price of Inflectra at this point. Our pipeline at a glance Updated August 2, 2022. All five biosimilars in Pfizer's clinical pipeline overlap with those in Hospira's, but even though only infliximab is required to be divested, the others could also be sold off to reach cost-saving targets. Sorry, you need to enable JavaScript to visit this website. Dr Ivo Abraham Column: When More May Yield LessPrice Erosion of Biosimilars Following US Market Entry, Teva Announces US Launch of Lenalidomide, Generic of Revlimid, Coherus Banks on 2022 Approvals After Net Losses for Q4, 2021, WHEN CHOICE ARRIVES: Competition & Consequences. veggie lovers pasta salad run fast eat slow; Bourgoin AF, Nuskey B. Pharmacoecon Outcomes News. Sarpatwari A, Avorn J, Kesselheim A. Inflectra (infliximab-dyyb) prescribing information. Joseph Azzinaro, commercial lead for biosimilars at Organon, predicted that PBMs will rapidly convert patients to adalimumab biosimilars. The first quarter of 2020 saw 3 biosimilars brought to market in the United States, 2 of them from Pfizer, and no new approvals from the FDA. An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the healthcare provider who prescribed the reference product.5, The Affordable Care Act made way for these biological products in 2010, allowing the FDA the authority to approve and regulate biosimilar products for marketing in the U.S.5 The Biologics Price Competition and Innovation Act of 2009 (BCPI Act), which was a part of this legislation, created a new abbreviated approval pathway under the Public Health Service Act for biological products that are shown to be biosimilar to or interchangeable with an FDA-approved biological product known as a reference product. stream
FDA. Trazimera has been approved as a biosimilar version of Herceptin to treat human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal . The company is based in Jersey City, New Jersey, but Organon revenues are expected to derive mainly (80%) from sources outside the United States. Please Note: Only individuals with an active subscription will be able to access the full article. Specifically, there are 3 key areas where we would like to see Congress and the administration focus: rebate reform, capping beneficiary cost-sharing in Medicare Part D, and incentivizing the uptake of biosimilars.. Barren Space Productions. Ontruzant has demonstrated strong sales in select European markets. ABP 654 is an investigational biosimilar to STELARA (ustekinumab). Forward-Looking Statements of Pfizer Inc. This includes legislation to require that 100% of negotiated rebates be passed through to consumers at the pharmacy counter. Accessed May 10, 2016.6. . Primary Menu. About the REFLECTIONS B7391003 Study Zarxio product information. It is Hospira's biosimilar pipeline . Zarxio (Biosimilar to Neupogen): Zarxio (filgrastim-sndz) was approved in March 2015, making it the first biosimilar to received U.S. approval.8 It is manufactured by Sandoz and is the biosimilar to Neupogen (filgrastim by Amgen). No single product is expected to represent more than 11% of its total revenue. In these materials, Pfizer discloses Mechanism of Action (MOA) information for some candidates in Phase 1 and for all candidates from Phase 2 through regulatory approval. Biosimilars This is one area where the two companies do have significant overlap. In this case, the prescriber will have to be contacted to change the prescription so that payment can be processed. helix-grid, helix-mega-menu, helix-layout-container, helix-core-grid, helix-core-header, helix-core-page-break, helix-core-card-group, helix-core-footer, helix-core-band { Quite simply, biosimilars will improve access to essential life-saving and life-enhancing medicines while helping healthcare systems face the challenge of mounting financial pressures. visibility: hidden; 6 0 obj
Meanwhile, Pfizer had also pledged to increase its investment to approximately $600m-$800m to bring further innovative monoclonal antibodies and vaccines into China at the site.
Fylnetra is the fifth Neulasta biosimilar, other biosimilars include: Mylan/Biocon's Fulphila (pegfilgrastim-jmdb), Pfizer's Nyvepria (pegfilgrastim-apgf), Coherus BioSciences' Udenyca (pegfilgrastim-cbqv) and Sandoz's Ziextenzo (pegfilgrastim-bmez) which are already available in the U.S. Our strong pipelineone of the most robust in the industryincludes biologics, small molecules, immunotherapies, and biosimilars, and is centered on exploring a wide array of approaches across many tumor types. Published by at 7 de novembro de 2022. OncologyLive, Vol. The recommended dosing is 5 mg/kg given as three injections at 0, 2, and 6 weeks, then every 8 weeks for all indications except in rheumatoid arthritis, whereby the recommended dose is 3 to 10 mg/kg up to every 4 weeks, and in active ankylosing spondylitis, where the maintenance regimen is 5 mg/kg every 6 weeks thereafter.12, Inflectra is contraindicated at doses higher than 5 mg/kg in patients with moderate-to-severe heart failure or a known hypersensitivity to infliximab products. 3) Educating practitioners: Pharmacists can provide useful information on the efficacy and safety of biosimilars, making them more comfortable with changing from a branded innovator product to a biosimilar. To date, only four biosimilars have been approved in the U.S. (Zarxio, Inflectra, Erelzi, and Amjevita), although many agents are currently undergoing trials and may soon become available. We're committed to treating 225M people with breakthrough treatments by 2025. As of September 2016, only four biosimilars had been granted approval from the FDA: Zarxio (biosimilar to Neupogen), Inflectra (biosimilar to Remicade), Erelzi (biosimilar to Enbrel), and Amjevita (biosimilar to Humira). Amgen Inc. Amgen pipeline. Since biosimilars were first introduced in the EU in 2006, 1.5 billion Euros in savings have been made in the EU5 . Pfizer Pipeline Snapshot 4 Pipeline represents progress of R&D programs as of October 30, 2018 TALZENNA (talazoparib) for treatment of patients with Included are 53 NMEs, 41 additional indications, plus 5 biosimilars Phase 2 Phase 3 Registration 35 28 26 11 Phase 1 Total 100 Discovery Projects 9 programs advanced or are new OK. We'll need you to sign in before we can determine if you are aligned with a sales representative. Pharmacists who have the most up-to-date knowledge will instill confidence in patients when discussing these new agents. Our Biosimilar products portfolio The information on this page is intended for healthcare professionals based outside of the U.S. so that they may learn about our portfolio offering in their region. We seek to translate the most innovative science into meaningful breakthrough medicines that redefine life with cancer for patients. The factory was built, but Pfizer said in March it had made a difficult decision to discontinue production activity in China and sell the installation to WuXi Biologics, a China-based company. endobj
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Accessed May 10, 2016.8. The move suggests Pfizer clearly values the biosimilars it has. Our Pipeline: Potential Breakthroughs in the Making We're in relentless pursuit of medicines and vaccines that will benefit patients around the world. Inflectra (Biosimilar to Remicade): In April 2016, the FDA approved the second biosimilar in the U.S., Inflectra (infliximab-dyyb), a biosimilar to Janssen Biotechs Remicade (infliximab), which was originally licensed in 1998.11 Inflectra is a tumor necrosis factor (TNF) blocker approved for the following indications12: Inflectra is available as an injection of 100 mg of infliximab-dyyb in a 20-mL vial for IV infusion. Our Biosimilars pipeline focuses on autoimmune diseases and oncology. Oncology Pipeline Bursting With Biosimilars. Its portfolio consists of more than 60 medicines and products. The global biosimilars market is expected to grow from $15.67 billion in 2021 to $19.10 billion in 2022 at a compound annual growth rate (CAGR) of 21.8%. Pfizer entered the biosimilar market through two avenues: (1) its acquisition of Hospira and (2) its own internal pipeline development. Categories . Three of these 5 products represented over $0.3 billion in full-year 2020 revenue for Merck: Renglexis, $135 million; Brenzys, $74 million; and Ontruzant, $115 million. Financial details of the acquisition have not been divulged, but a spokesperson from Indian drugmaker Biocon told . This site is intended for U.S. healthcare professionals. }p{v=CyCx^K^e^,>GVjY#)kt }=@
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Pfizer Inc. Pfizer biosimilars. 09, Volume 18, Issue 09. NEW YORK, NY, USA I December 13, 2017 I Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor . Biosimilars play a key role in helping generate meaningful savings for payers and health systems globally, while enabling increased access for patients to . None of the other significant players in the biosimilar industry (including Pfizer, Sandoz, Mylan, Amgen, Celltrion, or Biocon) have publicly announced a ranibizumab biosimilar . Pfizer-developed biosimilar medicine IXIFI (infliximab-qbtx) receives FDA approval for all eligible indications. Biosimilars hold the promise of reducing healthcare costs and improving patient access to high-priced biologics. The company said biosimilar revenues climbed 79% to $530 million, led by recent launches of rituximab (Ruxience), bevacizumab (Zirabev), and trastuzumab (Trazimera) biosimilars, as well as growth from the more established epoetin biosimilar Retacrit. Organon will sell these biosimilars in partnership with Samsung Bioepis of Republic of Korea. September 3, 2015. www.reuters.com/article/us-novartis-drug-idUSKCN0R30C220150903. 2004;1(4):24-29.5. April 5, 2016. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm. We believe biosimilars play a key role in creating a more sustainable health care system. According to a 2019 October update from Johnson & Johnson (J&J) the originator biologic Remicade notched third quarter sales of $749 million, down 24.1%. You may also be interested in. Home; The Quantum Leap Podcast; Thinking Outside The Longbox This is beneficial on many fronts, including: 1) Insurance claims processing: Insurance companies may only cover a biosimilar, while a prescriber may write the reference product. They would join already launched biosimilars Renflexis (Merck) and Inflectra (Pfizer). J&J attributed the sales decline to biosimilar competition. Biocad biosimilars. The use of Erelzi is contraindicated in sepsis.14. Since there are new developments in this field, pharmacists are encouraged to keep abreast of these changes by tracking FDA policies and state regulations. Officials of the new Organon enterprise said they are counting on sales growth from the following biosimilars: Renflexis (infliximab) in the United States, Aybintio (bevacizumab) in the European Union, and Hadlima (adalimumab) in Canada and Australia. Lake Forest, IL: Hospira; April 2016.13. http://biocadglobal.com/pipelines/Biosimilar. Erelzi (Biosimilar to Enbrel): On August 30, 2016, the FDA approved the TNF blocker etanercept-szzs (Erelzi, Sandoz), which is a biosimilar to etanercept (Enbrel, Amgen).13 Erelzi is approved for14: The recommended dosage for patients with rheumatoid arthritis and psoriatic arthritis is 50 mg SC once weekly with or without methotrexate. ABSTRACT: Following the legislation that allowed the FDA to approve biosimilars in the United States, biological products that are similar to the reference product in terms of safety, purity, and potency are gradually entering the market. Sandoz. An innovator drug company can manipulate the market for its products through rebates and thereby undercut the market absorption of biosimilars. The company is far less active in terms of biosimilar and complex generic sales in South and Central America, Africa, the Middle East, and Russia. Drugs Today (Barc). All rights reserved. The exclusivity period lasts for 12 years from the date of first licensure. An interchangeable biological product is biosimilar to an FDA-approved reference product and meets additional standards for interchangeability. This transcript may contain forward-looking statements about, among other things, our anticipated operating and financial performance, business plans and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, post-approval clinical . Also in July, FDA approved the biosimilar Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim). Cancer Treat Rev. It should not be administered to patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or pegfilgrastim products.9 Patients using Zarxio may typically complain of aching in the bones or muscles and redness, swelling, or itching at the injection site.9 More severe adverse effects include rupture of the spleen; serious allergic reactions leading to rashes, shortness of breath, wheezing, and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome.9, Zarxio saves patients about 15%, with the prices set at $275.66 for a 300-mcg syringe and $438.98 for a 480-mcg syringe as compared to Neupogen at $324.30 and $516.45, respectively.10. 1. CDER billable biologic product list; 2014. www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM164641.pdf. <>>>
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TABLE 1 lists some of the trials being conducted on biosimilars, and if successfully completed, these products may become available in the near future.17-22, A number of other biologics face the prospect of biosimilar competition based upon the exclusivity conditions outlined by the Affordable Care Act. The growth is mainly due to the companies resuming . The company launched bevacizumab (Zirabev), trastuzumab (Trazimera), and rituximab (Ruxience) biosimilars in the United States in 2020. Pfenex no longer lists this product (or any other biosimilar for that matter) on its pipeline. Our ambitions are big and our product pipeline has never been stronger. Indicated for the treatment of neutropenia, it is approved for use in patients with9: In line with the FDA requirements for the approval of biosimilars, Zarxio is available in the same formulations as Neupogen, prefilled syringes of 300 mcg/0.5 mL and 480 mcg/0.8 mL.9 The recommended starting dosage of Neupogen is 5 mcg/kg/day administered as a single daily SC injection by short IV infusion (15 to 30 minutes) or by continuous IV infusion.9 Zarxio should be administered following the same dosing schedule. %
Q3 2022 pipeline ( XLSX - 25.4KB ) At GSK, our pipeline is focused on unlocking the science of the immune system, human genetics and advanced technologies to develop vaccines and specialty medicines. Pfizer has a robust portfolio of potential biosimilar candidates in mid- to late-stage development. Major companies contributing to the global biosimilar pipeline analysis market include Amgen, Inc., F. Hoffmann-La Roche Ltd., Pfizer Inc., Novartis AG, Biocon, Merck & Co., AstraZeneca,. Pfizer's Herceptin Biosimilar Moving Forward Amid Rising Competition The Biosimilar Pipeline Analysis Market report aims to convey an inexpensive understanding of the business which has been analyzed by using primary and . Erelzi (etanercept-szzs) prescribing information. RETACRIT is Pfizer's third approved biosimilar in the U.S. Pfizer's biosimilars pipeline consists of 11 distinct biosimilar molecules with six assets in mid-to-late stage clinical development . We have also worked with state policymakers to advance legislation in several states ensuring that patient assistance provided by manufacturers will count toward the patients deductible and out-of-pocket maximums, Bourla said. Send. The year began with robust stock market performance and a much-touted partnership between the FDA and the Federal Trade Commission to . Accessed May 10, 2016.7. 2015;736(1):5.11. www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241719.htm. Infusion reactions such as fever, chills, chest pains, low or high blood pressure, shortness of breath, rash, and itching may occur 2 hours after infusion. Pfizer reported first quarter 2021 revenues of $14.6 billion, up 45% from the comparable year-ago quarter, and stated that increased biosimilar revenues partly helped fuel this growth, although the bulk of the revenue increase stemmed from $3.5 billion in sales of Pfizers COVID-19 vaccine, BNT162b2. Pfizer has a portfolio of three marketed biosimilar medicines outside the U.S. including INFLECTRA (infliximab), Retacrit (epoetin zeta), and Nivestim (filgrastim); and a biosimilars pipeline consisting of 13 distinct biosimilar molecules in various stages of development. According to a RAND report, from 2017 to 2026, biosimilars were estimated to save $US54 billion (up to $US150 billion) on biologic drug spending, which equals approximately 3% of total estimated biologic spending in the USA [ 3 ]. xTK#1V4LM"' March 6, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm. Sandoz: Unrivalled biosimilars pipeline. X1n=0b]OeH:bWJkx&4b0Qk
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Hadlima represents the largest biosimilar growth opportunity for Organon, as it will be among the first 2 adalimumab biosimilars to launch in the United States (June 2023). Pfizer is merging its off-patent branded and generic established medicines business with Mylan, in a deal that is scheduled to close later this month (November 2020) to form a new company, Viatris. <>
Furthermore, the FDA will not accept or consider potential applications for biosimilars until the fifth year after the approval of the reference product.5. All rights reserved. The BCPI Act also provides for a 12-year exclusivity period from the date of first licensing of the reference product before approval of any biosimilar can occur. During the first quarter, Pfizer announced it was withdrawing from biosimilars production within the China market. Allergan has been developing its biosimilar pipeline with Amgen and three of its four therapies overlap with. Accessed May 17, 2016.19. Biosimilar products under development at the time that were named as candidates for the China site included trastuzumab, bevacizumab, infliximab, rituximab, and adalimumab. New York, USA, Oct. 20, 2022 (GLOBE NEWSWIRE) -- The Global Biosimilars Market to Register Growth at a Massive CAGR of 21.54% During the Forecast Period (2022-2027) | DelveInsight Morrow T, Felcone LH. No launch date for Avsola has been announced. Accessed September 23, 2016.16. Overall, pharmacists can provide an objective perspective and educate prescribers and patients regarding biosimilars and their availability. }. IL-12 and IL-23. Copyright 2000 - 2022 Jobson Medical Information LLC unless otherwise noted. Amjevita (adalimumab-atto) prescribing information. Hadlima is scheduled to launch in the United States in 2023. Pharmacists are therefore encouraged to record adverse events and report them to either the FDA or prescribers. N Engl J Med. PF-07799933 BRAF Class 2 | Project advanced, CDK 4,6 kinase inhibitor ER-targeting PROTAC protein degrader, Braftovi (encorafinib) + Mektovi (binimetinib) | New project, Braftovi (encorafinib) + Mektovi (binimetinib) + Keytruda(pembrolizumab) | New project, BRAF kinase inhibitor andMEK inhibitor and anti PD-1, Braftovi (encorafinib) + Erbitux (cetuximab) | New project, sasanlimab (PF-06801591) + Bacillus Calmette-Guerin (BCG) | New project. Notable biosimilars companies include Pfizer Inc., Dr. Reddy's Laboratories Ltd., Amgen, Inc., Eli Lilly and Company, Novartis AG, Bioeq AG, Fresenius . Defining the difference: what makes biologics unique. Pfizer Pipeline Snapshot 4 Pipeline represents progress of R&D programs as of January 31, 2017 Included are 62 NMEs, 26 additional indications, plus 8 biosimilars Phase 2 Phase 3 Registration 36 17 32 11 Phase 1 Total 96 Discovery Projects 9 programs advanced or are new Pipeline represents progress of R&D programs as of May 2, 2017 Our strong pipelineone of the most robust in the industryincludes biologics, small molecules, immunotherapies, and biosimilars, and is centered on exploring a wide array of approaches across many tumor types. Pfizer's Biosimilar Earnings Pfizer reported first quarter 2021 revenues of $14.6 billion, up 45% from the comparable year-ago quarter, and stated that increased biosimilar revenues partly helped fuel this growth, although the bulk of the revenue increase stemmed from $3.5 billion in sales of Pfizer's COVID-19 vaccine, BNT162b2. Thousand Oaks, CA: Amgen Inc; September 2016.17. Information for Patients Click the button below to sign up to receive updates about Amgen Biosimilars. Patients commonly experience respiratory infections such as sinus infections, sore throat, headache, coughing, and stomach pains. The information provided is for educational purposes only. Prescribing Information for RUXIENCE (rituximab-pvvr), including BOXED WARNINGS and Medication Guide, Prescribing Information and Patient Information for NIVESTYM (filgrastim-aafi), Prescribing Information for INFLECTRA (infliximab-dyyb), including BOXED WARNING and Medication Guide, Prescribing Information for TRAZIMERA (trastuzumab-qyyp), including BOXED WARNINGS, Prescribing Information, Patient Information, and Instructions for Use for NYVEPRIA, Prescribing Information for ZIRABEV (bevacizumab-bvzr), Prescribing Information for RETACRIT (epoetin alfa-epbx) including BOXED WARNINGS and Medication Guide. Pipeline Biosimilar Products in the US (as of H1 2018) Biosimilar Approvals in South Korea (as of H1 2018) Patent Expiry of Major Biopharmaceutical Drugs Leads Way for Biosimilars 3 0 obj
Novartis launches first U.S. biosimilar drug at 15 percent discount. 8-16 In contrast, biosimilars have been available in Europe since 2006. September 23, 2016. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm. amgen pipeline biosimilars. FDA overview of biosimilar products. Pfizer's Infliximab Biosimilar Approved In US But Won't Launch Against Inflectra It is important that pharmacists dispense the agent with a patient medication guide that describes important information about its uses and risks.15,16, With a number of biological products soon to lose patent protection, more biosimilars are expected to enter the market. Organon Officials Introduce Their Biosimilars Strategy. Our pipeline provides an overview of our late-stage clinical development programs and is updated quarterly. <>
Progress and hurdles for follow-on biologics. Pharmacists can facilitate the use of these products by engaging further with prescribers, patients, insurance companies, and the FDA. Pfizer Pipeline Snapshot 4 Pipeline represents progress of R&D programs as of November 6, 2014 Included are 64 NMEs, 17 additional indications, plus 5 biosimilars Phase 2 Phase 3 Registration 33 29 22 7 Phase 1 Total 91 Discovery Projects 20 programs advanced or are new Pipeline represents progress of R&D programs as of February 27, 2015 It reflects the work we do here every day to break new ground with science that makes a difference in the lives of patients. 2022 MJH Life Sciences and Center for Biosimilars. To report an adverse event, please call 1-800-438-1985. Biologics vs. Biosimilars: Key Differences Explained With the potential to offer targeted therapies and reduced side-effects, the drive towards biologics is exciting. Pfizer increased its position in biosimilars through its $17-billion acquisition of Hospira in 2015. Accessed May 11, 2016.10. Although Chinese government reforms have improved the market for biologics producers, it remains challenging for foreign producers. Biosimilar is a type of biological product that is almost identical to the original product, which has undergone patent expiration. Pfizer has enjoyed dramatic recent success with biosimilars, reaping $525 million in biosimilar income for the fourth quarter of 2020, up 86% from the final quarter of 2019. FDA approves Inflectra, a biosimilar to Remicade. Accessed May 17, 2016.22. 2 - Being developed in combination with KEYTRUDA. Progress and hurdles for follow-on biologics. Press release - Coherent Market Insights - Biosimilar Pipeline Analysis Market | Biocon, Pfizer Inc., F. Hoffmann-La Roche Ltd, Amgen Inc., Kyowa Pharmaceutical Industry Co. Ltd - published on .