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    EMA shares lessons learned from biosimilars pilot

    The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Agency (EMA) to provide scientific advice to sponsors on their biosimilar development programs, according to a report on the agency’s recently concluded biosimilar scientific advice pilot.   Also, EMA found that current regulatory guidelines, which assume that developers will take a stepwise approach to biosimilar development where clinical studies are condu...
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    Cyltezo approved as interchangeable biosimilar with Humira

    An anti-inflammatory biosimilar from Boehringer-Ingelheim has received interchangeability designation from the US Food and Drug Administration (FDA).        Cyltezo (adalimumab-adbm) is now both biosimilar to and interchangeable with Abbvie’s Humira (adalimumab), announced FDA, which had granted biosimilar status to Cyltezo in 2017. Cyltezo is approved for all indications for which Humira can be used, including several inflammatory arthritides, Crohn’s disease and ulce...
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    Researchers: France could teach the US lessons in biosimilar pricing

    The US should look to the French healthcare system for lessons in reducing biosimilar pricing, according to a recent paper published in Health Affairs .   James C. Robinson, of the Division of Health Policy and Management, School of Public Health at the University of California Berkeley, and colleagues said the US “lacks consistent incentives for physicians to prescribe low-price biosimilars and for manufacturers to compete using price reductions” and that the slow up...
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    AAM: Medicare Part D plans slow to adopt generics

    Medicare Part D plans are slow to adopt generic medications for their beneficiaries, according to a recent report released by the Association for Accessible Medicines (AAM).   For the 2021 plan year, Medicare Part D formularies covered 21% of approved first generic medications from the previous year compared with the 66% covered by commercial formulary plans, the report stated. But this is part of a years-long trend, according to AAM. Not only do Medicare Part D plans ...
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    BsUFA talks progress on supplements, meetings and guidance development

    In the latest round of negotiations between the US Food and Drug Administration (FDA) and the pharmaceutical industry on the reauthorization of the Biosimilar User Fee Amendments (BsUFA), the two sides reached common ground on several topics, including supplements and labeling for product safety updates, meeting management and application review practices.   FDA and industry began negotiations on the third BsUFA program in March following a public kickoff meeting las...
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    Experts expect to see “second wave” of biosimilars approvals

    Experts expect to see a second wave of biosimilar approvals, though continued Medicare Part D reimbursement challenges hobble uptake, according to presenters discussing the current landscape and future projections for the biosimilars market at the annual meeting of the Association for Accessible Medicines (AAM) on 27 May.   “We have come a long way in the last two years,” said Craig Burton, vice-president of policy for AAM. Where you used to see one or two biosimilar p...
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    Woodcock cites 'vigorous interest' in biosimilar development

    Janet Woodcock, the acting commissioner of the US Food and Drug Administration (FDA), says there has been a “significant increase” in biosimilars approvals as the pharmaceutical industry has shown renewed interest in developing these drugs.   The agency has also met some of the “key deliverables” of its 2018  Biosimilars Action Plan  to develop a more competitive market for these products, said Woodcock, who gave the keynote address at the annual meeting of the Associa...
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    BsUFA talks continue on technology, regulatory science and reviews

    The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March.   During the two meetings, FDA and industry discussed issues related to application reviews, information technology, finance and staffing, regulatory science, review timelines and product safety updates. (RELATED: FDA, Industry set priorities for BsUFA III , R...
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    New laws address NCE exclusivity, biosimilar education

    Two bipartisan bills aimed at clarifying what constitutes a new chemical entity (NCE) and providing education on biosimilars to consumers and physicians were signed into law by President Joe Biden on Friday.   The first bill, S. 415 , also known as the Ensuring Innovation Act , amends the Federal Food, Drug, Cosmetic Act (FD&C Act) to replace the definition of an active ingredient with the active moiety definition used by FDA for the purposes of determining whether...
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    Insurance, physician barriers impede wider adoption of biosimilars

    Since 2015, the US Food and Drug Administration (FDA) has approved 29 biosimilar products, with some biologics having between four and five biosimilars now available.   When FDA approved the country’s first biosimilar, Zarxio (filgrastim-sndz) , the prospect that these products could help address the high cost of biologics and patient access issues seemed promising. However, the reality five years later is that uptake of biosimilars appears to be slow and inconsistent...
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    Biosimilars industry weighs in on BsUFA II interim assessment

    Three biopharmaceutical trade associations have weighed in with generally positive positions on an interim assessment of how the US Food and Drug Association has fared in its efforts to increase transparency and improve communication in its process for reviewing and approving biosimilars.   The comments follow a 27 January public meeting hosted by FDA that shared results of an external review of the agency’s Program for Enhanced Review Transparency and Communication fo...
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    CDER missing more BsUFA target dates amid pandemic

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) faced a mountain of work and logistic challenges during the COVID-19 pandemic. While the agency met most of its user fee goals, its performance in moving original biosimilar applications along fell short of the pace it kept in other areas.   A new report from CDER tracks how well the agency fared in acting on applications by type and by quarter, looking at the last two quarters o...