Biosimilar Regulatory solution center

  1. How Will Medicare’s International Pricing Index Model Affect Biosimilars?

    CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.

  2. What Biosimilar Metamorphoses Are In Store For 2019?

    In the second of this three-part "Ask the Board" series, Biosimilar Development's editorial board members discuss their predictions on how biosimilar development, market access, commercialization efforts, and regulatory and reimbursement policies will evolve in 2019.

  3. How Can The U.S. FDA, CMS, And HHS Help Biosimilars In 2019?

    In the second part of this two-part article, I unpack how the FDA could solve one particularly challenging market barrier and why we should expect to see (and call for) more from other government agencies in 2019.

  4. 2018 Biosimilar Triumphs And Tribulations: How Have Market Expectations Evolved?

    In the first part of a three-part “Ask The Board” series, members of the editorial board share what left them feeling the most heartened or concerned in 2018 and what must take center stage as we head into 2019.

  5. How Can The FDA Take Ownership Of Biosimilars In 2019?

    In lieu of the slow development of the U.S. biosimilar market, the FDA has stepped up to determine how it can improve biosimilar education, regulation, and market access. As many of the industry comments to the Biosimilar Action Plan revealed, this will require the FDA to continue broadening its purview and refining the regulatory pathway by implementing several specific actions.

  6. The Biosimilar Market Is Evolving: How Can Education Strategies Follow Suit?

    In this article, I’ll discuss the importance of one commonly overlooked expert and highlight one recent educational initiative that exemplifies current needs in biosimilar communication strategies.  

  7. Express Scripts New Flex Formulary: Biosimilar Friend Or Foe?

    Though it’s much too early to say for sure, we will need to watch how this formulary impacts the brand vs. biosimilar landscape, and, in turn, the performance of biosimilars in the pharmacy reimbursement space.

  8. How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?

    On Oct. 10, 2018, President Trump signed into law the Patient Right to Know Drug Prices Act, which, among other things, requires that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the FTC and the DOJ. This article summarizes the key provisions of the new law and discusses its limitations.

  9. If Four-Letter Suffixes Aren’t Used In Biosimilar Tracking, What Use Are They?

    The implementation of the Biologics Price Competition and Innovation Act1 (BPCIA) raised a number of critical issues for manufacturers, payers, and prescribers. These include the big-picture questions of extrapolation of indications, interchangeability, and a radical new approach to evaluating the comparability of these drugs to their reference biologics, as well as approving them.

  10. A Biosimilar Manufacturer’s Sword & Shield Against Doctrine Of Equivalents Claims

    While biosimilar manufacturers face many unique challenges in patent litigation, one of the most common is an infringement action brought under the doctrine of equivalents (DOE). DOE is a principle where a party sues for infringing on the general spirit of the patent, rather than on the specific content of its claims.