Only a few weeks into the new year, biosimilars or follow-on biologics already are occupying a prominent space in public policy and business developments. Following hearings in November 2010, FDA will continue to pave a regulatory pathway for biosimilars in the United States. On the other side of the Atlantic, the six-month consultation period on the draft guidelines issued by the European Medicines Agency on biosimilar monoclonal antibodies will end in May 2011. As these key regulatory matters are considered, both large and small bio/pharmaceutical companies are positioning themselves in the biosimilars market.

For example, Merck & Co. announced this week that it has formed a global clinical-development services agreement with the contract research organization Parexel for biosimilars. Under the agreement, Parexel will provide Merck BioVentures, the biologics and biosimilar division of Merck, with regulatory strategy and clinical-development planning capabilities for biosimilars, including exclusivity for certain candidates. The agreement also provides for the establishment of a dedicated Merck BioVentures unit within Parexel. Merck formed Merck BioVentures in 2008. Last year, Merck reported that it plans to have five biosimilar programs in Phase III development by 2012.

Merck is not alone in its biosimilar intentions. In October 2010, Pfizer formed a strategic global agreement for the worldwide commercialization with the Indian biotechnology company Biocon for biosimilar versions of insulin and insulin analog products (e.g., recombinant human insulin, glargine, aspart, and lispro). In an exclusive interview with Pharmaceutical Technology in September 2010, Lou Schmukler, senior vice-president of the specialty/biotechnology unit at Pfizer, said the company was evaluating its strategy in biosimilars and pointed to three potential areas for consideration: biosimilars (i.e., follow-on biologics which match the branded biologic as closely as possible); enhanced biosimilars (i.e., follow-on biologics with improved delivery, formulation, dosing or routes of administration); and biosuperiors, or drugs with a similar therapeutic target or mechanism of action, with structural changes and a new clinical profile that differentiates them from the original.

Sandoz, the generics arm of Novartis, which has three approved biosimilar products, announced this week that it has begun a Phase II clinical trial for a biosimilar version of rituximab, the active ingredient in Rituxan/Mabthera, a monoclonal antibody to treat non-Hodgkin’s lymphoma and rheumatoid arthritis, which is marketed by Roche/Genentech and Biogen Idec. The Phase II study is targeted to patients with rheumatoid arthritis and aims to demonstrate bioequivalence to the reference product by assessing data on pharmacokinetics and pharmacodynamics as well as efficacy and safety. Sandoz also reported that it has developed a high-yield and large-scale process for rituximab at its facilities in Schaftenau, Austria.

Monoclonal antibodies are considered an important and value-added part of the biosimilars pie, and a biosimilar rituximab is a likely first entry into this segment. The patents for rituxumab are expected to expire between 2015 and 2018 in the United States and in 2013 in the rest of the world, according to Biogen Idec’s 2009 annual report. Global sales of MabThera/Rituxan were CHF $6.1 billion ($6.1 billion) in 2009, according to Roche’s 2009 annual report. In addition to Sandoz, Teva Pharmaceuticals is developing a biosimilar version of rituxmab, according to a recent company investor presentation, and Mumbai-based Dr. Reddy’s Laboratories  has developed a generic version for the Indian market, according to the company’s 2009 annual report. Smaller companies are also getting involved in the fray. The biopharmaceutical company Spectrum Pharmaceuticals announced on Jan. 5, 2011, that it signed a letter of agreement with Viropro, a company that develops cell lines and manufacturing processes for biosimilars, for the development and clinical production of a biosimilar rituxumab. Also, in a Bloomberg/Business Week article this week, Biogen Idec, itself, alluded to an interest in entering into the biosimilars market over the next several years  although the company did not offer further specifics.

So what is next? Continue to look for positioning of both innovator companies (large and small) as well as generic-drug companies in the biosimilars market and foremost, watch for the crucial developments in FDA’s and EMA’s regulatory positions for biosimilars.