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.
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.
Although the biosimilar space is still growing and evolving in the U.S., it is comparatively well-established in India. According to the Generics and Biosimilars Initiative (GaBI), the first “similar biologic” was approved and marketed in India in 2000 — some 15 years before the U.S. approved its first biosimilar. India also has a much more mature biosimilar manufacturing ecosystem and regulatory environment than most other parts of the world. As such, the country can provide valuable lessons about what it takes to establish a thriving biosimilar market in terms of accessibility, competition, regulatory strategy, and other facets.
Pharmaceutical reimbursement historically has largely been a process of first determining the efficacy and safety profile of a therapy and then deciding its ultimate coverage level based on its price. But now, payers are taking a cue from their European peers and beginning to do the sophisticated number-crunching and cost-effectiveness studies to take a more holistic approach to drug coverage.
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.
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 goal is to achieve a balance between extension of patent protection and patent exemptions that make it easier to bring products to market in regulated industries. The commission specifically addressed the consultation to stakeholders in the biosimilar industry, among other regulated industries. The policy questions underlying patent extensions and research exemptions could have far-reaching impact on how quickly a biosimilar sponsor can get a product to market.
A recent FTC workshop on competition in prescription drug markets reflected a particularly interesting and exciting evolution within the regulatory space. And that has to do with what I consider to be growth in the FDA’s purview as a regulator.
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?
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.
What do patient groups want from biosimilar manufacturers, and what advice can they give companies to help shape their initiatives to educate stakeholders?
Accelerate more molecules to clinic with novel drug development approach.
Identifying the optimal formulation and dose form which shows an increase more than 20 times in the oral bioavailability of Salmon Calcitonin.
How an agnostic and data-driven approach early on can optimize the development pathway to bring the molecule to the market faster.
Over the past decade, advances in oncology research have resulted in many new treatment options that include immunotherapies. This article examines these newer therapies in more detail.
Single‑use fermenters are becoming an increasingly viable alternative to stainless steel, offering less time is spent on equipment preparation and qualification prior to start-up as well as routine maintenance and requalification of the equipment.
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