A biosimilar is a biological medicine which is highly similar, in terms of structure, activity, efficacy and safety, to another biological medicine (reference medicine) which is already approved by a regulatory authority.
The European Union (EU) has been a pioneer of biosimilar medicines’ regulation. The regulatory framework they have established, through gathering clinical evidence on safety and efficacy, has helped to shape the global development of biosimilar medicines.
In the EU, biosimilar medicines are approved via the European Medicines Agency’s (EMA) centralised procedure. Manufacturers of biosimilars are required to prove that there are no “clinically meaningful differences” to the reference product. Biosimilars can only be approved once the eight-year data exclusivity period of the reference product has expired. The EMA had published guidelines to assist manufacturers with conforming to the strict regulations for approval of biosimilars. They can be accessed here.
So, is the United States (US) Food and Drug Administration (FDA) doing enough to bring biosimilars to the market? Experts believe that the lack of biosimilar launches is due to legal issues such as the absence of administrative records on first licensures and exclusivity periods. Furthermore, they believe there is uncertainty regarding the return on investment that biosimilar manufacturers are experiencing.
Despite a slow start, the Japanese biosimilar market has witnessed accelerated growth. The countries financial incentives and commercial model, are and will be, the key to biosimilar market growth.
The International Generic and Biosimilar Medicines Association has called for increased regulatory convergence and collaboration between countries. They recently signed a memorandum of understanding with the World Health Organisation (WHO), noting that national regulatory frameworks aligned with the WHO guidance have led to the more biosimilar approvals with regulators.
Reducing the burden of clinical trials, speeding up registration and increasing access should be the common goal of global regulatory authorities. Universal biosimilar competition should improve patient access to safe and effective biological medicines with proven quality.