Latest Headlines

Latest Headlines

Biosimilars set to boom as new patent cliff on biologic superstars looms

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 to build $100M plant in North America

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.

Serum Institute allies with biotech in bid to cut cost of biosimilar production

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.

Sanofi's Lantus heir beats its forebear in controlling diabetes

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.

Pfenex eyes a $75M IPO to bankroll its biosimilars

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.

Glenmark opens new mAb manufacturing facility in Switzerland

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.

FDA breaks silence on biosimilars with long-awaited proposal

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's $4.5B in Q1 sales lags estimates, thanks to slow-selling Enbrel

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.

Big Pharma tries to short-circuit France's move toward biosimilar substitution

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 wins Herceptin patent suit in U.K., paving way for biosim

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.