Ms Lakshmi Balachandran, senior medical writer, Karmic Life Sciences
The first generation of biological therapeutics were developed in the 1980s. The global biological market represents one of the fastest growing sectors in the healthcare industry. With the end of the year 2012 and exclusivity period of most innovator biologics fast approaching, around $79 billion worth of innovator biologics are estimated to go off patent in 2015.
The global market for generic substitutes for original biologics is expected to grow to $10 billion by 2015. This surge can be attributed to the growing preference to targeted therapies, some of which have greater benefits over conventional drugs. However, unlike the conventional generic drug molecules, the complexity of the product coupled with lack of any knowledge on the innovator's clone, differences in the breakdown products and potential immunogenicity issues, pose serious challenges in introducing a generic equivalent.
The European Medicines Agency (EMA) has been very proactive in providing guidelines and creating a format for the approval of biosimilars.
In the US, the Biological Price Competition and Innovation Act (BPCIA) provides a framework for biosimilar approval. The USFDA has approved a few biologics through New Drug Applications (NDAs) and a few Follow-On Biologics (FOB) as Abbreviated New Drug Application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C) 505(b)(2) category; a rapid approval route. The FDA here relied on the safety and effectiveness of the reference product and not the applicant product. For instance, Sandoz's Enoxaparin and Amphastar's Enoxaparin were approved by demonstrating the similarities between the generic and innovator products.
In order to scale up to the ever growing demand for these products, manufacturing processes are often changed resulting in a completely new product development program. Extensive changes in the manufacturing process could impact changes in product attributes, warranting more data for ensuring similarity.