Biosimilar Regulatory solution center

  1. What To Watch In The Biosimilar Regulatory Space

    Though none of the regulatory issues discussed will be resolved right away, you can guarantee these will become regular parts of the dialogue between the industry and regulators in the years ahead.

  2. EU Turns Focus To Biosimilar Sustainability Questions

    As Julie Maréchal-Jamil of Medicines for Europe shared, the biggest questions in Europe now circle around sustainability — particularly whether market policies, procurement mechanisms, and benefit sharing models are in sync with the system's needs, and if they can teach nations that have yet to seize the biosimilar opportunity.

  3. Can Real-World Evidence Improve Market Access For Biosimilars In The U.S.?

    A look at the role real-world evidence (RWE) can play in increasing the uptake of biosimilars in the U.S. market and some of the challenges in leveraging the potential of RWE.

  4. Why The Biosimilar Industry Should Celebrate The Latest FDA News

    A number of articles already provide a synopsis of the FDA's reversal on the Statistical Approaches draft guidance. But I felt it was necessary to add one more article to this conversation, not only because this action is unprecedented thus far in the biosimilar industry, but it also suggests an important turning point in the FDA’s biosimilar oversight.

  5. “Locally Brilliant": 3 Biosimilar Market Access Experiences

    Mundipharma expert Richard Trollope shares his learnings from launching three different biosimilar molecules (Remsima, Truxima, and Herzuma) in the EU and discusses the questions that remain about the newly launched Herzuma, recently introduced in the U.K. and Germany.

  6. How Recent Regulatory & Payer Developments Impact U.S. Biosimilar Access

    In this second installment of a three-part series, industry stakeholders discuss recent developments in the U.S. marketplace from both the regulatory and payer viewpoints, with an emphasis on how these may lead to opportunities for biosimilar manufacturers.

  7. Critique Of Literature Review Highlights Areas For Future Study And Education

    A recently published literature review of biosimilar switching studies drew some pushback in the form of a letter to the editor. Though this letter may seem, on the surface, another frustrating bump in the road, it raises several new, important lines of inquiry for biosimilar makers and stakeholders to explore in future publications.

  8. Market Access Impediments: Where Should Biosimilars Go From Here?

    In this first article of a three-part roundtable industry experts share their insights on the status of the market for biosimilars and explore some of the reasons for the difference between the U.S. and Europe.

  9. Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility

    I’ve heard it said that innovation in the biosimilar world extends beyond the actual scientific and technical development of the product; innovation also applies to the act of changing and shaping regulations and perspectives. This year’s conference really emphasized the specific tasks being carried out by members of biosimilar companies, patient advocacy groups, payers, and research organizations to change and advance perspectives.

  10. Recent Supreme Court Decisions On Inter Partes Review — What Biosimilar Developers Need To Know

    The U.S. Supreme Court recently issued two decisions related to inter partes review (IPR). This article will briefly introduce IPR, discuss the Supreme Court’s decisions, explain how these decisions may impact IPR and biosimilar companies, and suggest how biosimilar companies should respond.