Biosimilar Regulatory solution center

  1. 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.

  2. 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.

  3. 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).

  4. The Post-Mayo World Of Life Sciences Patents

    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 this three-part series, we will look at how the U.S. Supreme Court’s jurisprudence on patent eligibility has evolved, examine the impact of its March 2012 decision in Mayo Collaborative Services v. Prometheus Labs, Inc. on life sciences patent litigation in lower courts, and discuss what it means for patent eligibility of biologic and biosimilar patents.  

  5. Biosimilars Face New Destiny Under Medicare Part B Revision

    Starting in 2018, CMS will heed calls to change its existing Medicare Part B policy. Though only time will tell the true impact of these changes, biosimilar makers, patients, and physicians stand to benefit in a few key ways.

  6. Tips For Success In The Indian Biosimilar Market

    In part 3 of this three-part series, Basak discusses the challenges of raising funds to develop and commercialize biosimilars in India, provides advice to biosimilar companies looking to enter the market, and shares his vision of the future for biosimilars in India.

  7. How This Medicare Part D Proposal Gives Biosimilars Chance To Shine

    Establishing new language requiring a portion of rebates to be passed on to consumers at the point-of-sale could bode well for biosimilar makers, and especially those that provide a competitive price.

  8. Will EU Patent System Changes Speed Market Entry For Biosimilars?

    In October 2017, the European Commission issued a consultation seeking input from the public regarding whether improvements can be made to the patent system. The policy questions underlying patent extensions and research exemptions could have a far-reaching impact.

  9. CMS’ Decision On Coding For Biosimilars: A Deeper Look

    The November 2017 decision by CMS to change the coding practice for biosimilars in the United States is likely to have far-reaching consequences for these drugs, but will all downstream effects be positive?

  10. The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers

    Control of the Remicade and biosimilar market is being aggressively contested by Janssen, J&J, Celltrion, Hospira, and Pfizer. This article discusses the legal issues being decided in each of the federal court cases surrounding Remicade.