• 6 Important Elements Of The New STRONGER Patents Act

    Over the past decade, patent reform has been an area of emphasis for Congress, with the passage of The America Invents Act of 2011 (AIA) and, more recently, the filing of a revised version of the STRONGER Patents Act in July 2019.

  • A Biopharma Year In Review — And A Look Ahead To 2020

    The industry has shown surprising resilience and consistency, emerging relatively unscathed from the recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and a recession-resistant risk profile.

  • CMS Star Ratings: Will Biosimilars Benefit?

    The Centers for Medicare and Medicaid Services (CMS) star ratings system was created in 2007 for insurance plans operating under both the Medicare Advantage and Part D. This 1 to 5 system (with 5 being the highest rating) is a way for CMS to measure the value of a plan and determine whether to continue to allow it to be part of the program. However, it’s more than just the plan, since the plan’s providers play a key role in how CMS evaluates each plan.

  • ISO 10993: Considerations For Drug Delivery Devices

    A host of factors come in to play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.

  • Biosimilars: Lessons Learned From Regulatory Approvals

    This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to ensure faster approval of biosimilars.

  • Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers

    The clock is ticking for state lawmakers to preserve an existing law that allows for prescription drug coupon usage in Massachusetts with an end-of-the-year deadline fast approaching.

  • Can The FDA Salvage Interchangeable Follow-On Biologics?

    Learn the statutory and regulatory requirements for interchangeability designation, how the designation hampers follow-on biologics, and why the FDA should loosen requirements for the designation.


Anna Rose Welch article header




Biosimilar approvals in the U.S. are being granted at a quicker pace, but the allure of tailored biosimilar development that lowers or eliminates dependence on large comparative clinical trials remains a long-term, highly sought-after goal. This free collection of articles examines several of the FDA’s most recent high-profile guidances and how certain regulatory decisions will (or will not) advance the biosimilar industry.

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