Biosimilars

Biosimilars

Biosimilars, also known as Follow-on-biologics, are products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. A product can only be made that is similar, but not identical because of the complexity of biologics. Biotechnology-derived products are complex proteins that are extremely difficult for even the innovator to manufacture. Minor changes in the manufacturing process can inadvertently result in significant and possibly dangerous differences to the final product. We believe that because of the differences between biologics, challenging issues exist relating to the development, approval and marketing of biosimilar products. In addition, patient safety must be of paramount consideration when evaluating these issues. Despite these challenges, the Biosimilar market will emerge and flourish and the key to success will be getting to market first with the correct molecules, and selecting the right strategies.

A biosimilar product would be approved based on an analytical determination that the product is similar to the innovator product. Due to the importance of trade secret protections, the biosimilar sponsor would not have access to the cell line or the critical manufacturing processes that are essential to production of the innovator product. As a result, a complete analytical comparison with the Reference Product is necessary to support approval of a biosimilars along with the clinical data needed to support similarity to an innovator product.

CuriRx is well positioned to provide following expertise in developing biosimilars and compare it to the innovators’ product:

  1. Analytical method development and characterization
  2. Limited Preformulation/Forced Degradation studies
  3. Formulation assessment
  4. Lyophilization cycle development if necessary
  5. Comparison with the Reference product