Biosimilar Regulatory solution center

1. Maybe Biosimilar Applicants Should Dance After All 6/30/2020

   The decision to engage in the BPCIA patent dance with a reference product sponsor is rarely black and white. Early dismissals in cases like Eagle v. Slayback and Amgen v. Coherus are just one factor a biosimilar applicant should consider.

2. 3 P’s In A Pod: Keys For Building A Successful U.S. Biosimilars Market 6/29/2020

   In listening to several speakers during a BIO Digital panel, these three talking points added some clarity to the slowly growing discussion on what U.S. biosimilar success will look like.

3. Why It’s Time For A U.S. Biosimilar Shared Savings Model 6/17/2020

   There's been much discussion about launching a biosimilar shared savings program through the CMMI. In this Q&A, Biosimilars Forum president Julie Reed discusses why this is the best path forward for the U.S. and how The Forum and its members are preparing to ensure its success. 

4. How Canada Built A Framework For Biosimilar Transitions In Its Provinces 6/10/2020

   Two experts from The pan-Canadian Pharmaceutical Alliance and Cancer Care Ontario discuss the efforts they undertook and challenges they still face in establishing consistent cross-province implementation policies for biosimilars.

5. Canada’s Nuanced Healthcare System: Biosimilars In The Private Sector 6/3/2020

   The first of this two-part article portrays the complex makeup of the Canadian healthcare system and current stakeholder needs as it relates to biosimilar switching, with a specific focus on the results of one private payer's transition program.

6. Biosimilars In An Election Year: What To Expect 4/9/2020

   Christine Simmon, the executive director and SVP of policy and strategic alliances for the Biosimilars Council shares several leading biosimilar policy efforts that are front-of-mind for the Council, paying a closer look, as well, to some of the potential limitations of the proposals as they stand now.

7. Aligning With Cancer Centers To Spur Biosimilar Uptake 3/31/2020

   During our conversation, Pontchartrain Cancer Center COO Kathy Oubre shared what biosimilar makers can do to balance both sustainability and promote cost savings while also supporting cancer centers and their healthcare professionals.

8. Biosimilars In The Pandemic Age: Current Impact And Market Implications 3/26/2020

   This has been a very exciting time for those in drug discovery, while it’s been a bit quieter on the biosimilar front (understandably). That said, I’ve come across a few tidbits of knowledge here and there about the impact this pandemic may or may not yet be having on the biosimilar space.

9. Recent Conference Portrays Progressively Sophisticated Biosimilar Market 3/20/2020

   As many of the points shared at the recent World Biosimilar Congress suggest, there have been enough big triumphs in the U.S. and other countries that the discussions surrounding biosimilar education and implementation have and will continue to grow increasingly nuanced.

10. 3 Pressing Questions From The FDA/FTC Biologics Competition Workshop 3/13/2020

    After taking at least 20 pages of notes from the FDA/FTC biologics competition workshop, I’ve whittled my takeaways down to three overarching questions that provide necessary considerations and industry action steps moving forward.