India’s Cipla outlines big biosimilars plans, new R&D deals

India's Cipla is beefing up its investments in biotech, with plans to invest more in Asia's burgeoning biotech companies while spearheading the development of new biosimilars for cancer and preparing to take the wraps off a new R&D center. Cipla has been quick to grab significant stakes in a variety of biotech companies, including its investment in Stempeutics Research, which is pursuing new stem cell therapies. At its annual meeting, Cipla Chairman Y. K. Hamied bullishly reviewed the...

Big Pharma takes on risk with biosimilar programs

Companies like Pfizer, Teva and Hospira are among the developers trying to get an early jump on the biosimilar drug market. A pathway for biosimilar drugs was approved when the healthcare bill was approved earlier this year, but the FDA has yet to set out clear guidelines for development of the copycat drugs. But big companies can't resist the call of the potentially lucrative market for generic biologics. Pfizer is set on creating "bio-betters," Hospira is in the process of...

Hospira plans big study for new Epogen biosimilar

In what's described as an early-stage clinical trial, Hospira (NYSE: HSP) has unveiled plans to take its biosimilar of Amgen's anemia drug Epogen directly into a head-to-head study designed to swiftly pivot into a large, late-stage study. The Chicago-based company plans to recruit hemodialysis patients at 20 different centers across the U.S. But unlike a typical Phase I study, researchers will immediately study both safety and efficacy of the therapy, Retacrit, in comparison with the...

Only the biggest developers can play the biosimilar game

Over the next five years, the market for biosimilars will swell to $10 billion, but only a handful of players with deep pockets and world-class R&D facilities will be able to play. And that means that most small- and medium-size drug developers will never have a chance of leaping into the new market for follow-on biologics. "You are not going to see small shops being able to enter this market... There are only five to six players that are credibly going to play a role," Michael Sjoestroem,...

Cipla targets $19B biosimilar market with string of new deals

India's Cipla is paying $65 million to buy a significant minority stake in two Asian biotech companies with plans to develop a range of discounted biosimilars. And Cipla's chairman says he specifically wants to create follow-on therapies to three of Roche's top biologics--Avastin, Herceptin and Enbrel--that account for $19 billion in annual revenue. "Avastin, Enbrel, Herceptin--these are all being marketed today, but the prices are very high," Cipla Chairman Yusuf Hamied, who built the company...

Hospira gains EMA OK for Neupogen biosimilar

Hospira says that it won European approval for its follow-on therapy to Amgen's blockbuster Neupogen. In winning the OK, Hospira provided late-stage data demonstrating that its therapy, Nivestim (filgrastim), had a comparable efficacy and safety profile to Neupogen. Europe has sprinted ahead of the U.S. in its approval of biosimilars, follow-on therapies to the biologics like Neupogen that have dominated the market for years. This is the fifth European approval for a biosimilar to...

Roche plots a survival course but sees no big biosimilar threat

As far as Roche CEO Severin Schwan (photo) is concerned, the European economic crisis will trigger deep cuts in healthcare spending, leaving room for only two types of Big Pharma players: Generic drugmakers with the economies of scale needed to market huge volumes of cheap therapies and innovators who can come up with a new generation of therapies that offer markedly better outcomes for patients. All others, he says, will perish in the economic storm. "If pressure increases you will have...

Teva pioneering a biosimilar to compete with blockbuster Rituxan

Teva Pharmaceutical is taking aim at Roche's blockbuster Rituxan, confirming reports that it is developing a biosimilar of the monoclonal antibody. Bloomberg reports that Teva appears to be on track to develop the first monoclonal antibody follow-on, one of the pioneers in a coming wave of biosimilars that is expected to start gaining approval around 2013 and 2014. Teva is studying TL011 as a replacement biologic for rheumatoid arthritis patients now on Rituxan. The therapy, Roche's second...

‘New Merck’ spotlights late-stage strategy but shelves biosimilar

Merck brought out its top guns at this morning's R&D meeting to make a bullish case for its late-stage prospects in the wake of a $41 billion mega-merger with Schering-Plough. Regulators in the U.S. and Europe are reviewing applications from Merck on four NMEs, and the Big Pharma company plans to file for five more approvals later in the year. Meanwhile there are 20 programs in late-stage development. Up for approval this year is a new contraceptive, an extended-release version of the...

Pfizer developing “bio-betters,” seeking rare blood disorder drugs

Anyone doubting Big Pharma's interest in developing biotech drugs should check out a new report in the Wall Street Journal detailing Pfizer's work on three large molecules now in mid-stage development. Dow Jones, meanwhile, reports that Andrew Callos, vice president of commercial development of endocrinology and hematology in Pfizer's specialty-care unit, is seeking new pacts on programs for rare blood disorders. "A lot of these smaller disease needs have gone unmet," Callos told the news...