Many generic developers have experience in both manufacturing and gaining US and EU approval for generics which are small molecule alternatives to the authorised original products. These developers possess the relevant skillsets to allow them to pursue the development of biosimilars, which are large molecule biologics highly similar to the authorised original products.

However, unlike generics, biosimilars cannot be shown to be identical to the previously authorised products (often know in the field as the ‘originator product’). Therefore, new challenges and considerations must be accounted for and addressed to enable successful development. This article discusses the potential challenges faced and suggests risk mitigation strategies to help ensure successful entry into the biosimilars market.