Vartika Pandya and Ross Shahinian co-wrote this blog post with Tucker Herbert.
To address healthcare system costs, the Biologics Price Competition and Innovation Act established an abbreviated pathway for less expensive copies of biologic drugs called biosimilars. Biosimilars have struggled to penetrate the U.S. market, including those developed by major players. Biosimilars of Remicade (infliximab) have managed to capture only 6% of the U.S. market 21 months post-launch. By contrast, the EU has witnessed a more rapid uptake of biosimilars, likely due to stronger payer control and regulatory guidelines facilitating biosimilar penetration (such as the NHS commissioning framework for biological medicines in the U.K.). In the U.S., the FDA has followed suit by developing the Biosimilars Action Plan (BAP) to strike a balance between innovation and competition in the U.S. biologics market.
Biosimilars Action Plan,
Disparate uptake of biosimilars to date show that developing a biosimilar is far from a sure bet. Launching any new drug is challenging, but launching a biosimilar can be especially tricky because of the increased uncertainty across regulatory, legal and commercial spheres on one hand and an expectation that significant promotional effort will be required (without being able to differentiate on safety/efficacy) on the other. Is choosing between biosimilars (or an originator) making a therapeutic choice? In the eyes of the FDA, unless a biosimilar has been granted interchangeability, the product choice remains with MDs as the products have been deemed to have equivalent safety/efficacy without being identical. (Other key stakeholders are developing a range of perspectives on this topic.) To ensure commercial success, biosimilar developers (and defenders) need to have a strategic plan for forecasting and conducting market research to fully understand the market complexity. It’s also critical to align the incentives for providers, patients, payers, pharmacists and procurement—all of whom can play a critical role in driving or delaying a new biosimilar’s uptake.
new product launch,