Biosimilars Striving for US Uptake

Abstract

Though biosimilars have to go through an abbreviated regulatory pathway for approval, it is quite challenging given the scientific and technical complexities associated with these products. As an increasing number of biologics face patent expiration, biosimilars offer an attractive opportunity. While companies would be desiring to have a footing in the developed markets like US and EU, considerable opportunities exist in developing/emerging markets. With more number of biosimilars making their commercial foray, starting to gain acceptance across formularies, the leading biologic players have started taking a hit on price, volume and market share of their blockbuster drugs. The pace of sales erosion due to biosimilars is expected to be gradual yet relentless. Since the enactment of Biologics Price Competition and Innovation (BPCI) Act, 12 biosimilars have been approved by the US Food and Drug Administration (FDA) till September 2018. However, only a small percentage have seen the light of the day in terms of commercial launches. These are primarily driven by legal challenges and hesitancy from insurers and healthcare providers. While originators have been trying all the means at their disposal to thwart competition by posing challenges, the biosimilar players are striving to take them head on with the anticipated revenues in mind. Stakeholders have made key recommendations to increase the uptake of biosimilars in US market. Regulatory agencies have to play a key role in promoting confidence in biosimilars among healthcare practitioners and patients. The FDAs much awaited Biosimilars Action Plan (BAP) is expected to revive the sedentary biosimilar market in the US. The medical community, payers, and the FDA should work together for ensuring the approved biosimilars are adopted and prescribed in a manner to bring down overall healthcare costs.