The biogenerics market, long hindered by a lack of regulatory framework, is now showing signs of development. With patents for the earliest biopharmaceuticals to reach the market beginning to expire, the first biogeneric products are anticipated to reach the regulated markets in North America and Europe by 2006-2007. Products such as generic erythropoietin, recombinant human growth hormone and recombinant human interferon are anticipated to be the first product launches following abbreviated routes to market, representing a multi-billion dollar market for competitors within this sector.
Regulatory issues have been the biggest challenge to the development of the biogenerics market in North America and Western Europe. This challenge is now showing signs of easing, particularly in Western Europe where the European Agency for the Evaluation of Medicinal Products is now accepting Market Authorisation Applications for biogeneric products, which show proven biosimilarity in place of clinical trials.
A reduction in clinical requirements has the potential to speed the progress of biogeneric products to market by bypassing lengthy clinical trials. However, regulatory agencies are focusing their attention on developing tools and procedures to assess biosimilarity without compromising drug safety. However, reductions in clinical requirements for biogeneric products have the potential to significantly reduce the cost of finished products compared to those of the original patented products. Costs incurred through drug discovery and development may be redirected to product reverse engineering and process engineering.
Manufacturers of biopharmaceuticals now face the loss of commercialisation rights conferred by their drug patents. The earliest biopharmaceuticals such as recombinant human insulin have lost patent protection, and many other drugs such as the blockbuster anaemia treatments incorporating recombinant erythropoietin will follow suit between 2005 and 2007.
Biopharmaceuticals originators are responding to this threat using a range of tactics to stave off competition from biogenerics manufacturers and deter them from penetrating their blockbuster markets. With multi-billion dollar revenues at stake, these companies are fighting back by reformulating existing products to improve efficacy, implementing more efficient delivery systems, and engaging in high-level intellectual property battles.
Given that the manufacturing costs for biogenerics are much higher than those of conventional, small molecule pharmaceuticals, developing proprietary expression systems could help minimise costs. Manufacturers also need to ensure their products are bioequivalent and produced at full cGMP standards.