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  • 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

    European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Updates Biosimilar Guidance to Allow Comparators of US Origin The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in biosimilar clinical trials. Swissmedic is now allowing biosimilar developers to use comparators sourced from the United States. That marks a change in the policy Swissmedic established whe...
  • European Regulatory Roundup: France Targets 80% Biosimilar Penetration by 2022 (4 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news . Ireland Offers to Waive Certain Fees to Ease Impact of Brexit Ireland is offering to waive the fee for certain Brexit-triggered regulatory requests. The offer will allow companies to change their reference member state (RMS) from the United Kingdom to Ireland for free. Officials from the Health Products Regulatory Authority (HPRA) of Ireland made the offer in guides on ...
  • Regulatory NewsRegulatory News

    Best of 2017: What Readers Clicked on This Year

    From Trump to biosimilars to a new digital health pilot run by the US Food and Drug Administration (FDA), here are the top 10 most-read articles of 2017, with some updates on what has occurred since the stories were published. 10. EMA to Suspend More Than 300 Drugs due to Unreliable CRO Studies Back in March, the European Medicines Agency (EMA) recommended the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies w...
  • Regulatory NewsRegulatory News

    Updated: The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US

    Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years. In September, FDA granted tentative approval for Sanofi’s Admelog (insulin lispro injection), a rapid-acting human insulin analog. On 11 December, Admelog received full approval from FDA. In the EU, howe...
  • 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 Shifts Coding and Payment Policy for Biosimilars Under Medicare Part B

    The Centers for Medicare and Medicaid Services (CMS) late Thursday announced that it would finalize a policy to separately code and pay for biosimilar products under Medicare Part B, signaling a win for industry. CMS said it is making the change as it was "persuaded that that there is a program need for assigning Part B biosimilar biological products into separate HCPCS [Healthcare Common Procedure Coding System] codes, specifically that this policy change will addr...
  • Regulatory NewsRegulatory News

    Sandoz Raises Questions With FDA Draft Guidance on Statistical Approaches for Biosimilars

    Martin Schiestl, chief science officer at Novartis' Sandoz, on Tuesday explained how the US Food and Drug Administration's (FDA) draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly. Schiestl told attendees of DIA's biosimilars conference in Bethesda, MD, that the problem is related to equivalence testing, which FDA says in the draft, "is typically recommended for qu...
  • 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

    Interchangeable Biosimilars vs. Biosimilars: Experts Explain Guidance, Discuss Development and Uptake

    Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' Regulatory Convergence on Monday. Leah Christl, associate director for therapeutic biologics at the US Food and Drug Administration (FDA), on Monday presented on a recently released FDA draft guidance for industry on interchangeability , outlining the studies necessar...
  • Regulatory NewsRegulatory News

    FDA Approves 6th Biosimilar in US, Second for Humira

    The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab). Cyltezo, which follows the approval of Amgen's Amjevita (adalimumab-atto) last September , has been approved for multiple indications (see link to label below), did not go before an FDA advisory committee and was not approved as an interchangeable biosimilar. How...