With the market for biosimilars expected to spiral, drug research providers Celerion and Ricerca Biosciences have allied to extend their services to customers developing copycat versions of biologics. The alliance's preclinical and early-stage clinical services appear to mirror those offered to developers of original biologics.
Which shouldn't be a surprise to some. Last month, the FDA issued guidance on the regulatory pathway for biosimilars, making it clear that developers would have to jump through some of the same kinds of hoops that are in place for new biologics. Unlike small-molecule generics, biosimilars won't be exact copies of the original products, and U.S. regulators will likely want to see new clinical evidence to support bids for approving biologic knockoffs.
With an idea of the regulatory bar that biosimilars makers will face in the U.S., Celerion and Ricerca have compiled services that they believe will provide developers data that they need to advance agreements with regulators on the design of trials and seek FDA OKs to test biosimilars in patients. Those services include testing biosimilar activity in animals and lab studies as well as immunological and toxicology studies, the companies said.
"Ricerca Biosciences is well positioned in Europe, Asia and North America to enhance the success of [the alliance with Celerion]. Biosimilars are a rapidly growing segment of the market, and we see increasing demand from our clients for safety and efficacy testing to assess viability," Ian Lennox, Ricerca's CEO, said in a statement. "The Biosimilars Alliance is an important step for Ricerca in supporting the future needs of our clients."
The companies estimate that the market for biosimilars is due to skyrocket from about $2.4 billion this year to $44 billion by 2020. The market has already seen an uptick in the number of interested biotech and pharma outfits jumping into the biosimilars fray in recent months, including Biogen Idec ($BIIB) via its Samsung deal and Amgen ($AMGN) with partner Watson Pharmaceuticals ($WPI).
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