So The Process Is Not The Product?
Some of the suspicion around biosimilars emanates from a once universally accepted catch-phrase: “The process is the product.” This mantra served to alert the world that only one manufacturer—usually the speaker’s company—was capable of producing a biotherapeutic.
Kenneth Hughes, a co-founder of PlantForm could not disagree more. “Process does not equal product. Product equals product,” he chuckles. While processes must be validated, it’s the end, not the means, that’s important. “Besides, if your process is so subtle that it alone can produce a product, I question your validation data.”
PlantForm is attempting to enter biosimilars markets through transgenics, a scientifically elegant approach that has received little respect. The company, which expresses therapeutic proteins in nicotinia plants, plans to make biosimilars of three cancer drugs with global sales in 2009 of more than $23 billion. The company estimates markets for its biosimilar products at $2 billion per year by 2016 and $4 billion by 2020.
The company’s pipeline leader is trastuzumab (Herceptin/Roche). PlantForm claims its version of the drug has purity and activity equal to Herceptin’s, but costs only 5% as much to manufacture.
Dr. Hughes recognizes the difficulties and the history, but notes that this time is different. Advances in analytic technology enable “much more exquisite characterization for demonstrating the equivalence of biologics,” he says, not to mention surrogate assays for efficacy. “But safety—particularly acceptable immunogenicity—is more difficult to prove.”
Despite the economic uncertainty surrounding biosimilars, the pharmaceutical and biotechnology industries are forging ahead. Novartis with two biosimilars on the market, continues with its biogeneric strategy, while Merck’s BioVentures division announced a collaboration with Parexel in January 2011.
At the recent “J. P. Morgan Healthcare Conference” in San Francisco, Biogen Idec CEO George Scangos predicted that biosimilars would become “a meaningful source of revenues” for his company within a few years. Even Samsung, the consumer electronics giant, announced a $389 billion investment in biosimilars in 2010.
Yet Roche, in deciding to defend its $6 billion-per-year Avastin franchise against competition from biosimilars, is staying on the sidelines. Or is the company hoping that U.S. regulators remain in a state of bewilderment? Roche has a lot of time to change its mind, as the drug does not lose patent protection for another eight years.