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  • Regulatory NewsRegulatory News

    Biosimilars Forum Calls for FDA Guidance to Address Misinformation

    Echoing a Pfizer petition and Novartis comments, the Biosimilars Forum said late last week that guidance from the US Food and Drug Administration (FDA) is needed to ensure reference product sponsors and other organizations communicate properly about biosimilars.   Amgen, which withdrew from the Forum recently, Roche’s Genentech and others have been singled out for misinformation campaigns that not only question the legal framework governing biosimilars but also the saf...
  • Regulatory NewsRegulatory News

    Drugmakers Call for Changes, Additions to FDA’s Purple Book

    The US Food and Drug Administration’s (FDA) Purple Book for biosimilars needs some modifications and new information to be more useful, pharmaceutical companies told FDA in recent comments. According to FDA, the Purple Book includes the date a biosimilar or biologic was licensed and whether FDA evaluated the biological product for reference product exclusivity. It also includes whether a biological product has been determined by FDA to be biosimilar to or interchangea...
  • Regulatory NewsRegulatory News

    Mylan and Novartis to FDA: Where are the Suffixes?

    Mylan and Novartis are taking issue with the fact that the US Food and Drug Administration (FDA) has yet to begin issuing random suffixes for biologics’ names and so far has only used suffixes for biosimilars and a few recently approved biologics, according to comments released Wednesday. “The agency has not yet retroactively issued suffixes to any reference product for which there is a corresponding biosimilar. Given the agency's silence about this practice, there are ...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About Biosimilars

    For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption. What is a Biosimilar? A biosimilar medicine (also sometimes k...
  • Regulatory NewsRegulatory News

    Evaluating Analytical Similarity: Stakeholders Raise Questions With FDA Draft Guidance

    Biopharma companies and industry groups, including Pfizer, Genentech, Boehringer Ingelheim and the Biosimilars Council, have raised detailed questions in recently released comments on the US Food and Drug Administration’s (FDA) draft guidance on statistical approaches to evaluate analytical similarities for biosimilars. Back in September, FDA released the 15-page draft guidance on the type of information sponsors should obtain about the structural/physicochemical...
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    FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin

    The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s blockbuster breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India. First approved in the US in 1998, Herceptin had US sales of more than $2 billion for the 12 months ending 30 September 2017, according to IQVI...
  • Regulatory NewsRegulatory News

    EMA Backs Six Drugs, One Biosimilar for EU Approval

    The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval. The six medicines the agency is recommending are: Dr. Falk Pharma's Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the esophagus. Jorveza was granted an accelerated assessment and orphan designation; Merck Sharp & Dohme's Pr...
  • Regulatory NewsRegulatory News

    CMS Shift on Biosimilar Reimbursement Under Part B: What to Expect

    The Centers for Medicare and Medicaid (CMS) last week announced a major shift in how it will reimburse for biosimilars under Medicare Part B, and though the agency and market might not see the full impact of the decision for another decade, experts explained to Focus what the change will likely mean in the near and long term. And though the predictions are largely hypothetical (since there are not currently multiple biosimilars for any reference biologic on the mar...
  • Regulatory NewsRegulatory News

    CMS Revisits Biosimilar Payment Policy: Industry Comments Signal Expected Changes

    A tweak to a Centers for Medicare and Medicaid Systems (CMS) billing code system that could come later this week would have a big impact in making US biosimilars more competitive with their reference products. Background CMS' Medicare Part B program currently pays for biosimilars under the Physician Fee Schedule (PFS) based on the average sales price (ASP) of all biosimilar products within the same Healthcare Common Procedure Coding System (HCPCS) code, which means...
  • Regulatory NewsRegulatory News

    Will FDA Add Suffixes to Approved Biologics' Names?

    Back in January, the US Food and Drug Administration (FDA) finalized guidance on how biosimilars and their biologic reference products' names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name. But between January and now, of the biologics and biosimilars approved, only the biosimilars' names have included the random four-letter suffixes. The discrepancy leads to questions of inequity between the two pro...
  • Regulatory NewsRegulatory News

    WHO Will Hold Off on Using Biological Qualifiers for Biosimilars

    No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report. The US Biosimilars Council praised the WHO move , which follows the US Food and Drug Administration’s (FDA) use of a system in which biosimilar nonproprietary names come with a f...
  • Regulatory NewsRegulatory News

    Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B

    Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018. The deal between the two companies means that AbbVie’s Humira, which was first approved by FDA in 2002 and accumulated sales of more than $130 billion in its first 15 years on the market, will be on the U...