Guest Columns

1. Biosimilar Litigation Review: BPCIA Cases Settled Or Dismissed In 2019 1/21/2020

   This is the second article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding Biosimilars Price Competition and Innovation Act district court litigation and reviewed ongoing BPCIA district court cases. In Part 2, we turn our attention to BPCIA district court cases that were settled in 2019.

2. Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law? 1/16/2020

   Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

3. Biosimilar Litigation Review: Ongoing BPCIA District Court Cases To Watch 1/14/2020

   In many ways, last year was a notable one for biosimilars in the U.S. During the 2019 calendar year, the FDA approved the 26th biosimilar product, and the 12th biosimilar product was launched in the U.S. market (with more expected to launch in the coming weeks).

4. 6 Important Elements Of The New STRONGER Patents Act 1/9/2020

   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.

5. A Biopharma Year In Review — And A Look Ahead To 2020 12/16/2019

   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.

6. CMS Star Ratings: Will Biosimilars Benefit? 12/5/2019

   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.

7. ISO 10993: Considerations For Drug Delivery Devices 12/4/2019

   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.

8. Biosimilars: Lessons Learned From Regulatory Approvals 11/26/2019

   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.

9. Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers 11/22/2019

   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.

10. Can The FDA Salvage Interchangeable Follow-On Biologics? 11/19/2019

    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.