Biosimilar Regulatory solution center

41. Biosimilar Industry Experts Highlight 2019 Triumphs, Tribulations 12/11/2019

    As we close out another year of global biosimilar successes and twists and turns, it’s always important to take stock on just how far we have come and where we still hope to go as an industry. As in years past, I reached out to members of Biosimilar Development’s editorial board and several other experts to get their take on the past year's progress.

42. Inside FDA’s Latest Biosimilar “Game Changing” Guidance 12/9/2019

    Overall, there are three broad takeaways to both celebrate and consider about the FDA’s latest clarification of the biosimilar regulatory pathway as it relates to insulin biosimilars.

43. 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.

44. Biosimilar Competition Is Here To Stay In 2020 12/5/2019

    Following Peter Bach’s controversial argument to “throw in the towel” on biosimilars, I reached out to three economic experts for their perspectives on how to create a functioning, competitive biologics marketplace and which economic and government policies will be the best to pursue for long-term success.

45. The Biologic, Biosimilar Insulin Transition: The Patient Perspective 11/29/2019

    In this article, a patient advocate from the JDRF shares the diabetes community’s perspective on the upcoming regulatory transition of insulins and how the industry can better engage and educate patients about the future presence of insulin biosimilars.

46. Real-World Evidence & Biosimilars: Weighing The Potential Impact 11/26/2019

    Here, IQVIA’s Jaclyn Bosco, Sandoz’s Edward Li, and the University of Messina’s Dr. Gianluca Trifirò discuss how RWE can impact regulator and payer decisions, shape treatment pathways, and encourage greater stakeholder comfort and action toward biosimilars.

47. 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.

48. Transition Biologics: FDA, Industry Examine Regulatory Nuances 11/22/2019

    Though these experts all believe this transition should go off without a hitch and will not hinder insulin access, there are several overarching regulatory and educational considerations the industry should be aware of as March continues to creep closer.

49. 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.

50. 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.