Biosimilar Development solution center

  1. The Past And Future Of Managing Raw Material And Process Risks In Biomanufacturing

    How far have we come in raw material supply management, and what still needs accomplished to ensure the delivery of safe and effective drugs?

  2. How Can We Make FDA’s Biosimilar Action Plan A Game-Changer?

    Despite all the FDA’s efforts to increase review time and get products to market more quickly, I remain unconvinced that the BAP will turn around the U.S. market — at least not our current market. So what can we do in the meantime?

  3. Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?

    Gone are the days when we could count the number of immunology drugs on the market with our two hands. Today, the market is crowded with not only an abundance of originator biologics, but also an increasing supply of biosimilar products

  4. 4 Revelations From The FDA’s Biosimilar Part 15 Hearing

    In addition to laying out some of the concerning themes that came up throughout the hearing, I will unpack some of the FDA’s lines of inquiry which I feel illuminated the agency’s efforts to challenge certain claims for the first time. 

  5. Biosimilar Access: Is The Industry Overlooking Critical Markets?

    Though there’s much to write about the successes and pitfalls in the European, U.S., and Canadian biosimilar markets, it turns out there’s quite a bit that biosimilar makers need to learn about the countries off the beaten market-access path. And in many of these nations, the capacity for a biologics market already exists.

  6. What Brazil Can Learn From Denmark’s Biosimilar Policies

    In this article I continue to outline some of the Brazil Ministry of Health's biggest questions about post-market surveillance, big data, and procurement, as these are particularly telling of how the nation’s biosimilar policy could take shape in the future.

  7. How The Regulatory Pathway Shapes Biosimilar Business Decisions

    I took the opportunity to pick editorial board member Hubert Chen's brain about the ins and outs of the 505(b)(2) pathway, which led to an even larger discussion about the critical impact a regulatory pathway can have on a company's business decisions and strategies.

  8. What Can Biosimilar Developers Learn From The 1990s Biopharma Industry?

    This article highlights some of the early biologics industry decisions and thought processes and the subsequent actions and opportunities biosimilars create for the pharma industry.

  9. Biosimilars In Brazil: Healthcare Salvation Or Waterloo?

    I was recently given a first-hand look at some of the unique market-related challenges standing in the way of Brazil taking full advantage of biosimilars. In the first of this two-part article, I will provide a closer look at some of these challenges and what these may mean for the Brazilian biosimilar industry moving forward.  

  10. A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief

    This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.