Hot Topics Related to Biosimilars and the BPCIA

At the beginning of June, the American Conference Institute held a two-day event in New York focused exclusively on recent developments related to biosimilars and their treatment under the Biologics Price Competition and Innovation Act (BPCIA). This conference took place immediately before the argument at the Federal Circuit in the Amgen v. Sandoz case, which has at its center the question of whether the BPCIA's so-called "patent dance" is mandatory or not before a biosimilar can be marketed in the U.S. It should be noted that according to current statistics, of the top ten highest revenue generating drugs in the world, the overwhelming majority are protein-based pharmaceuticals. This makes the market a proverbial goldmine for companies looking to launch biosimilars.

Many issues were discussed at the conference, including the interplay between the BPCIA and the Federal Trade Commission (FTC), naming conventions for biosimilars, substitution reporting obligations at the state level, and of course, a discussion of the BPCIA's patent litigation provisions, among other things.

With respect to the FTC, the discussion focused on potential antitrust issues that may arise in relation to settlement of litigation involving biosimilars. Most believe that the Supreme Court's decision in FTC v. Actavis regarding "pay for delay" settlements in the Hatch-Waxman context will eventually be applied to biosimilars.

With respect to naming conventions there is a debate over whether there should be a single, non-differentiating name for protein based pharmaceuticals. Most biosimilar companies appear to want a single name to avoid the type of discrimination that allegedly occurs between innovator drugs and generics on the small-molecule side. In addition, most biosimilars actively object to any kind of identifier added to a pharmaceutical's name which identifies the manufacturer, again because of concerns related to discrimination.

On the subject of substitution of biosimilars, many states are currently debating legislation regarding what reporting obligations pharmacists will have to prescribers if the patient or its insurer requests a biosimilar. The proposals include, among others, having to get preapproval from the prescriber, having to report back to the prescriber if a substitution was made, having to make a notation in the patient's medical record of a substitution, and no reporting at all. Many on the biosimilars side are opposed to the first two of these because, they argue, it will place too great a burden on the pharmacists/pharmacies. Some believe that even if the reporting is required after the substitution is made, it is tantamount to getting preapproval because once the biosimilar has been given to the patient, it cannot be returned to the manufacturer. Indeed, many pharmacies may not even order biosimilars until they get prescribers' approval for fear that they will get stuck with a large dollar investment that cannot be returned to the manufacturer if it is not prescribed. Most on both sides of the argument appear to be willing to compromise with a requirement that pharmacists make a notation in the patient's medical records if/when a biosimilar is prescribed. This details of the various proposals are currently playing out in state legislatures all over the country.

Regarding the BPCIA's patent dance, most are waiting to see how the Federal Circuit rules in the Amgen v. Sandoz case that was argued earlier this month. See "Patent Dance Takes Center Stage in Amgen v. Sandoz Appeal" Law360 (June 4, 2015). In addition, however, there are other avenues that companies are investigating in an effort to get biosimilars to market, including challenging patents through the various post-grant procedures, and possibly filing actions in the International Trade Commission (ITC). Post-grant procedures present some downside risks to petitioners because statistically, patents related to the chemical and biologic arts are deemed more unpredictable and thus, have a higher survival as compared to other technologies. ITC actions also have their limitations. It only offers help to innovators who are worried about biosimilar companies that are importing products. (Note: this may include biosimilar companies which manufacture in the U.S., send them abroad for packaging, and then re-import them to the U.S.) And, the sole remedy is an injunction to stop importation. Nonetheless, it may provide innovators an additional avenue of protection.

Other topics discussed included the difference between biosimilars and "interchangeables" under the BPCIA, and whether bridging studies conducted abroad may be used to meet the requirements for biosimilar approval in the U.S. What was made clear from the discussions at the conference is that there are still many more questions than answers as it relates to how biosimilars market will develop in this country, and how the BPCIA will impact that development. It is believed that it will take 5-10 years for many of these issues to ripen and be resolved. In the meantime, we will continue to analyze and report on these and other issues in this evolving area.