Biosimilar Regulatory solution center

  1. What’s New in U.S. Biosimilar-Land?

    A lot has been promised with the introduction of biosimilars, but can they really deliver a viable alternative treatment to biologics at a substantial savings?

  2. How These Hospital Stakeholders Can Benefit Biosimilar Commercialization

    In Cinfa Biotech’s time preparing for regulatory submission and, hopefully, a future product launch, Jankowsky has noted the increasingly significant role pharmacists play in educating doctors. Much of this comes down to their holistic method of approaching biosimilars — and this was integral in establishing the company’s rationale for development.

  3. What Challenges Should Biosimilar Companies Expect In 2018?

    Whether they be IP-,real-world-data-, or ongoing market-access-related challenges, biosimilar companies should expect a busy year ahead. Biosimilar Development's editorial advisory board members share the challenges they're keeping their eyes on.

  4. 2018 Outlook: Biosimilar Trends To Watch

    Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

  5. Patent Eligibility Of Biologic & Biosimilar Patents — A Primer

    To be entitled to a patent, an invention must satisfy a number of patentability requirements, including the “patent eligibility” requirement under 35 U.S.C. § 101.  Part 1 and Part 2 of this three-part series reviewed the origin and history of the patent-eligibility requirement and jurisprudence and how the U.S. Supreme Court’s decisions since Mayo Collaborative Services v. Prometheus Labs, Inc. significantly raised the patent-eligibility bar, and examined the impact of Mayo on life sciences patent litigation in lower courts. 

  6. Did The 2017 Biosimilar Industry Pave The Way For A Productive 2018?

    In the first installment of this three-part Q&A, I asked the members of the inaugural Biosimilar Development editorial advisory board to share their thoughts on significant 2017 developments and how they expect these will impact the industry in 2018.

  7. What Types Of Life Sciences Patents Are Vulnerable To Section 101 Challenges?

    To be entitled to a patent, an invention must satisfy a number of patentability requirements, including the “patent eligibility” requirement under 35 U.S.C. § 101.  In Part 1 of this three-part series, we reviewed the origin of the three “patent ineligible” subject matters, the evolution of the U.S. Supreme Court’s jurisprudence on the issue, and how the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Labs, Inc. changed the patent-eligibility landscape for life science patents.

  8. Biosimilar Evolutions To Watch For In The New Year

    Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

  9. What U.S. Biosimilar “Traditions” Need To Be Broken In 2018?

    You may feel “tradition” is not yet a realized concept in the biosimilar industry — and I would agree with you. But this didn’t stop me from asking several experts which areas they felt could stand more attention or redirection in the future. And they left no stone unturned.

  10. Why So Slow? Demystifying The Barriers To U.S. Biosimilar Adoption

    This article will provide a glimpse into the complex and often misunderstood dynamics of U.S. biosimilar reimbursement that contribute to the state of the market today — a topic that is particularly salient in light of recent policy changes by the Centers for Medicare & Medicaid Services (CMS).