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.
For years, the FDA has been unveiling its plan for regulating knockoffs of blockbuster biologics in fits and starts, this week outlining just how it wants to define biosimilarity for would-be copycat drugs.
Amgen reported a mixed bag of results in the first earnings period following its acquisition of Onyx Pharmaceuticals. First-quarter revenues came in approximately $230 million lower than consensus, a miss that the company attributes primarily to sluggish sales of Enbrel.
Late last year, French legislators quietly slipped a measure into the country's 2014 budget legislation that would allow pharmacists to substitute inexpensive biosimilar drugs for pricier biotech brands. While not a full-out assault on branded biologics, it would make France the first European country to substitute the cheaper drugs, and the pharma industry is doing everything it can to derail that move before France's Administrative Supreme Court decrees it into effect.
Hospira is one step closer to selling a Herceptin biosimilar in Britain. The U.S.-based drugmaker persuaded a U.K. court to overturn two Roche patents on the drug. And that means, as of now, Herceptin (trastuzumab) could be open to biosim competition when its main patent expires July 28.