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? As the decision is applauded by various prescriber, patient, and industry groups, it is key to investigate the events that could ensue from the decision, and whether it will stimulate the U.S. biosimilar industry, which languishes behind that of other geographies.
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?
In the first of this two-part article, four patient advocacy groups share the level of knowledge their members have surrounding biosimilars and what types of strategies they have enacted to educate their patients.
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.
During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”
The recent settlement of the patent war involving Amgen’s biosimilar to AbbVie’s Humira (adalimumab) has caused rippling in the pharmaceutical industry. The companies had been battling worldwide since at least as early as August 2016, when AbbVie filed a lawsuit against Amgen in the U.S. District Court for the District of Delaware.