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Are biosimilars really similar?

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Tags: Bioprocess

Biosimilars or follow-on biologics are biological products that are similar in terms of quality, safety and efficacy to a reference biotherapeutic drug, which is already marketed and whose patent has expired or is about to. They, however, differ from generics since their chemical structure is not an exact “copy-paste” of the patented drug (1). They are considered to be one of the fastest growing sectors of the pharmaceutical industry and there is a renewed global interest, especially in emerging markets. The high cost of branded biologics is placing enormous financial pressure on nationalized healthcare systems of developing countries. Substituting branded biologics with lower-cost biosimilars can help reduce government healthcare costs and lessen the financial burden of insurance companies and third-party payers. Countries like China, Brazil and Russia depend largely on biotherapeutics from foreign manufacturers and suppliers. As a result, this has often led to rising drug prices and shortages therefore preventing patients from accessing potentially life-saving drugs. Biosimilars represent an interesting and viable opportunity for emerging economies to build domestic biotechnology capabilities and it would, in turn, allow them to compete more effectively for a share of the global pharmaceutical industry.


The turn of this decade marks the end of patents covering some of the top ten-selling biologics, which include anti-inflammatory therapeutics such as Humira® or Remicade® and anti-cancer drugs such as Avastin® or Herceptin®. This opens the door for more companies to develop biosimilars. The global market is expected to increase to $3.7 billion by 2015 as more patents expire (2). However, the impending expiry of patents and the approval of biosimilars can be perceived as both good and bad with new economical opportunities potentially overriding risks for the patients. Indeed, biologic products are “large complex molecules” compared to “small molecule” drugs. Contrary to the latter whose synthesis can be replicated in a laboratory, biologic products and biosimilars depend on variables such as post-synthesis modifications of products in the host cells. They are more complex in structure and also more difficult to manufacture with consistency. Thus, demonstrating the “biosimilarity” of a biologic product is, by no means, an easy feat as a considerable amount of clinical safety and efficacy data will be required to prove that the biosimilar is just as safe and efficient as the reference product. Issues such as effectiveness, safety, naming and most importantly, interchangeability are being discussed for regulatory approval. The FDA is currently in the process of finalizing guidelines for biosimilars.

Some of the world’s largest pharmaceutical and generic companies (e.g. Hospira, Merck, Pfizer, Sandoz and Teva) have already entered the biosimilars market. Last year, the European Union granted the marketing authorization of 14 biosimilars, which have been successfully used in Europe since then. Progress in Europe should, hopefully, help speed up the process around the world and notably in the United States. In fact, July 24, 2014 was a landmark day for the American biotechnology industry. Sandoz, the generic arm of Novartis, announced that the U.S. Food and Drug Administration (FDA) approved for the first time the commercial launch of a biosimilar of Amgen’s Neupogen® (Filgrastim), a biologic used for treating neutropenia, a common side effect of chemotherapy. In the future however, forging a single regulatory framework between the European Union and the United States for biosimilar drugs should be envisaged in order to cut down significantly the costs associated with biosimilar development and avoid duplication of clinical trials (3).

Enzo Life Sciences offers a comprehensive portfolio for studying biosimilars including our novel BioSims™ conformational ELISA kits for 3-D conformational comparison, higher-order structure (HOS) characterization, between biosimilars and marketed monoclonal antibodies. In addition, Enzo offers a long list of tools for bioprocess, some of which are listed below:

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  1. International Federation of Pharmaceutical Manufacturers and Associations. Similar biotherapeutic products – Scientific and regulatory considerations. IFPMA (2013) 1-20.
  2. D. Beasley and L. Richwine. Drugmakers gear up to copy biotech drugs in U.S. Reuters (2011).
  3. J.L. Fox. Indiana jumps the biosimilars gun. Nat. Biotechnol. 32, 406.

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