5 of the Biggest Controversies in Biosimilars in the Year 2019

With drug costs continuing to spiral and slower uptake in the United States compared to other parts of the world, it is perhaps natural for observers of biosimilars to ask questions, not only about well-known patent issues, but about deeper issues, such as the way biosimilars are developed, the meaning of interchangeability, and perhaps the very structure of the industry itself. Here’s a look at 5 hot topics from 2019:

5. Are Authorized Biologics Poised to Hold Back Biosimilars?

Supporters of authorized generics—which are the same products as brand-name drugs but may have minor differences, such as different inactive ingredients or different colors or markings—say that these cheaper versions of existing products can help mitigate skyrocketing prices for patients. But not everyone shares the view that authorized generics are a boon, and in 2019, concerns began to rise that the marketplace may soon see the advent of authorized biologics.

4. Biosimilars Council White Paper Condemns Patent Abuses, Defends Patent Settlements

The Biosimilars Council, a part of the Association for Accessible Medicines, issued a white paper in June 2019 condemning abuses of the patent system that delay biosimilar competition. The white paper says that the low number of available biosimilars in the United States is a “direct result of the patent schemes used by some brand-name pharmaceutical companies to maintain their lucrative product pricing monopolies” and estimates that the financial impact of these delays has cost the US healthcare system $7.5 billion in lost savings since 2015 and $7.6 billion since 2012.

3. Time to Take a Science-Based View of Biosimilar Interchangeability, Paper Argues

The differences between the European and US understandings of the term “interchangeability” have led to misunderstandings of the concept of interchangeability in the biosimilars context, particularly with respect to physician-led switching of patient from one product to another or to pharmacist-led substitution. One 2019 paper argued that interchangeability should be recognized as a scientific concept, and one that is inherent to the very nature of biosimilarity.

2. Time to Replace the Totality of the Evidence Approach to Biosimilars?

A 2019 paper argued that the current method of biosimilar development, which relies on a “totality of the evidence” approach, is unnecessarily burdensome and costly and should be replaced by a new paradigm. Such a change would maximize the societal benefits of biosimilars by optimizing the regulatory burden on developers and encouraging multiple parties to develop biosimilars and engage in robust competition, the paper argued.

1. Bach, Coauthors Call for Regulated Pricing for Biologics as an Alternative to Biosimilars

An argument in favor of the government regulating prices for biologics kicked off months of discussion in various forums and continues now, becoming the most watched controversy in biosimilars in 2019. The 2-part proposal from Peter B. Bach, MD, and 3 coauthors argues that biosimilar competition is an economically inefficient way to achieve the goal of lower prices, and that while the biosimilar—biologic relationship is often compared to the one that exists in the generic marketplace for small-molecule drugs, there are fundamental differences. The piece was published on the Health Affairs blog, which subsequently published counterarguments.