As the FDA considers whether it should approve recently filed biosimilar versions of Johnson & Johnson's Remicade and Amgen's Neupogen, a parade of pharma companies, physicians and payers is coming forward to voice their concerns, not the least of which is how these products will be named. Now another group of concerned parties has joined the chorus: investors.
Ever since the FDA drafted a set of rules for biosimilars in 2012, a debate has been raging over whether those drugs should carry the same generic names as the products they emulate. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have different names than branded biotech drugs.
Biosimilars promise huge potential, with estimates for this decade running from $35 billion to $200 billion and growing exponentially from there. And of course the U.S., being the world's largest pharma market, presents the greatest potential, once someone breaks in and acceptance can be judged.
South Korea's Celltrion is aiming to be second in line when biosimilars make their U.S. landfall, filing an FDA application to market a knockoff of Johnson & Johnson's blockbuster Remicade.
If you look at the biosimilars market as a global whole, the sum total of revenue generated by the follow-on crowd just barely crossed into blockbuster territory in 2013, according to a new study from Allied Marketing Research. But that $1.3 billion base is expected to swell to $35 billion by 2020 as new products penetrate the market in North America, Europe and Asia.
Glenmark has more than a dozen manufacturing plants around the world, recently opening a mAb manufacturing facility in Switzerland to feed its pipeline of monoclonal antibodies and biosimilars. But the Indian generics maker does not have a plant in North America and figures it is time.
The biosimilars market has attracted some big companies with even bigger claims about their ability to drive down manufacturing costs, with Samsung and its ambition to undercut biologic prices by 50% the standout example. Now a small Australian biotech is trumpeting the cost-saving it can realize after marrying its expression technology to the scale of the Serum Institute of India.
Across three Phase III trials, Sanofi's in-development replacement for Lantus was better at battling low blood sugar than the company's cash cow insulin product, providing hope for the drugmaker's diabetes business when its blockbuster goes off patent next year.
San Diego biotech Pfenex has evolved from helping Big Pharma craft large-molecule therapies to developing biosimilars of its own, and now the company is looking to raise about $74.8 million to cash in on the coming boom in biologic knockoffs.
India's Glenmark, which is working on both novel monoclonal antibodies and biosimilars, needed more manufacturing capacity for its clinical trial work and so has brought online a new mAb manufacturing facility in Switzerland.