Market entry of biosimilar monoclonal antibodies
Current barriers, how they could be removed and what will be the economic and other impacts of their removal
The impressive market success of monoclonal antibody drugs (mAbs) and their upcoming patent expiry, have lead many companies to start biosimilar mAb development. They all seek to gain share in the multibillion-dollar mAb market. For healthcare payers biosimilar mAbs promise a great savings opportunity and may contribute to sustaining the increasing cost of medical treatment. The European Medicines Agency (EMA) has designed a regulatory pathway to support biosimilar mAb development but multiple barriers stand in the way of their potential market success. Complex production, clinical trials, marketing and compulsory post-authorization safety studies make biosimilar development expensive, compared to the development of small molecule generic drugs. The South Korean company Celltrion demonstrated that with the right combination of resources and capabilities a biosimilar mAb can be developed and its biosimilar infliximab gained market approval in 2013. Subsequent market entry and success are dependent on intellectual property (IP) challenges, reach of the innovator, the impossibility of substitution and interventions by healthcare policymakers. The absence of a worldwide regulation on market entry and patent issues limits the potential market size. The removal of market entry barriers will lead to increased biosimilar competition and possibly a generic-like market, where competition is price driven. The biosimilar developer can make the highest profit in a brand-like market with a small number of competitors and competition driven by differentiation. The availability of biosimilar mAbs will lead to healthcare savings in the medium-term but this might not be sustainable in the long-term if price erosion occurs.