Biosimilar development, potential and challenges

As major biological medicines currently on the market approach the end of their patent protection, drug manufacturers around the world are exploring the possibility of producing “generic” biopharmaceuticals – known as “biosimilars” or “follow-on biologics” – that would increase the availability and lower the price of these life-saving products. The success of the original biologicals demonstrates the tremendous potential for biosimilar therapies. However, this opportunity is tempered by significant scientific challenges and unanswered questions about how to define and regulate biosimilar products.

Biosimilar challenges

There are several key issues surrounding biosimilar products that remain subject to debate – issues that could delay or preclude the introduction of many follow-on biologics. These concerns stem from the prevailing scientific and regulatory view that a generic biological cannot be identical to the innovator drug – only “similar” – if it is expressed from a different cell line than the original. As a result, a follow-on protein created by a generic manufacturer cannot be approved for marketing in the same way as a small-molecule generic drug. Instead, biosimilar manufacturers must provide additional clinical and non-clinical data to demonstrate the product’s equivalent safety and efficacy – a process that will dramatically increase the time and cost to create follow-on biologics.

In addition, regulations covering the market approval of biosimilars are still evolving around the world. The European Union (EU) has led the way in establishing regulations for follow-on biologics, including a directive outlining the process to gain regulatory approval for biosimilars. Several biosimilar products have already been approved under these regulations by the EU Commission. Elsewhere, the regulatory landscape varies dramatically. In parts of Asia, biosimilar products have been on the market for several years; in the United States, no regulations for follow-on biologics have been established, although they are under consideration.

The many uncertainties surrounding biosimilars create significant hurdles for companies hoping to bring follow-on biologics to market. The key to success in the biosimilars market is to organize a cross-disciplinary team with expertise in biological products, clinical development, regulatory affairs, and medical practices to carefully plan a development strategy. 

Biosimilar and follow-on biologics development experience

PAREXEL's extensive experience with biosimilar compounds makes us one of the few companies that truly understands the regulations, the opportunities and the challenges of developing biosimilars. Our expertise in biosimilar development and marketing includes:

• PAREXEL Consulting, with unparalleled medical, scientific, and regulatory experts who have worked on more than 100 consulting and clinical projects for follow-on biologics – including two successful EMEA biosimilar submissions
• PAREXEL Clinical Research, with comprehensive service offerings for every phase of biosimilar development, and biosimilar trial experience involving more than 3,500 patients

Although the concept of biosimilar products is clearly still in its infancy, it offers a very promising future as a powerful vehicle for bringing more-affordable biological therapies to patients around the world. PAREXEL’s unique blend of scientific, regulatory, clinical, technology, and business resources make us the ideal partner to help you meet the challenges of biosimilar development and stay at the forefront of this emerging field.

For more information about how PAREXEL can help you build your biosimilar/follow-on biologics development program, follow the links above, or contact us by email at info@parexel.com.