Pharmaceutical Technologist - March 2008 - (Page 10)

Market watch The battle for biosimilars Europe urgently needs cheaper medicines, but are health professionals and patients ready to accept biosimilars? Sylvia M. Findlay ounting pressure on European healthcare budgets has created a pressing need for cheaper alternatives to expensive drug classes. The patent loss of top-selling biologics has opened up opportunities for budding biosimilars, but an array of challenges remains to be faced. M Developmental challenges Biologics have been used to treat various diseases including multiple sclerosis, anaemia, cancer, growth hormone deficiency, and certain rare genetic disorders; however, the manufacturing process is highly complex. Throughout, it is crucial to keep the molecule biologically active. Minute pressure or temperature changes can cause the biologic to lose its safety and efficacy, and each manufacturer develops their own proprietary standards during the manufacturing process to ensure high quality. Before reaching the patient, every biological medicine must be subject to stringent assessments through preclinical and clinical trials. Biosimilars (copycat versions of original biologics) are developed after patent expiries. They are designed to have the same pharmacokinetic properties of the original, but are considered different to traditional generic drugs. Generics are identical to their branded counterparts, whereas the complex manufacturing process of biologics has initiated much debate and concern regarding the approval and marketing of biosimilars. It is extremely difficult to prove that a biosimilar has an identical nature to the original biologic. Analytical tests are insufficient to demonstrate the clinical properties of biosimilars, and specially designed preclinical and clinical trials must be conducted. Compared with generics, biosimilars take considerably longer to develop — it takes approximately 6–9 years for a biosimilar to be approved, and only 2 years for a standard generic. An innovative marketing approach is also required for a better reach among physicians. The pricing of a biosimilar is often approximately 20% lower than the original brand, but this alone may not be enough to sell the product, making an innovative marketing scheme a crucial factor for a biosimilar. Regulatory burdens Regulatory issues surrounding the approval of biosimilars have formed major barriers to market entry. Ambiguous regulatory processes and lack of clarity in the parameters for approval are the major challenges in getting biosimilars approved in the EU and US. The need to establish similarity to the original biologic has been an overriding challenge to market players. A regulatory process in the EU has been established for the launch of biosimilars. After proving the safety, quality and efficacy, biosimilars can be launched once the patent of the original biologic has expired. Having approved five biosimilars since 2006, the EU is the pioneer in biosimilar approval when compared with the US. Although the US has discussed regulatory processes for biosimilars, debates on the nomenclature, potential pitfalls and unresolved issues have delayed progress. In addition to regulatory hurdles, biosimilars face tough post-marketing challenges, such as resistance from doctors to switch patients from the original brand to a biosimilar. Although biosimilars are often lower priced than innovator brands, concern regarding their similarity exists in the minds of physicians and patients. Such negative perceptions restrain the widespread use of biosimilars. 10 MARCH 2008 PHARMACEUTICAL TECHNOLOGIST

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Pharmaceutical Technologist - March 2008 Contents News Morpheus Market Watch E-procurement Means Lean Procurement The Rational Enquirer Simulating for Success Q&A

Pharmaceutical Technologist - March 2008

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