ViewPoints: Amgen shows first hand in biosimilars market – key observations

Big Pharma turns to biosimilars

Having announced their planned collaboration in the oncology biosimilars space in December, Amgen and Watson provided the first real insight into their strategy on Wednesday, when Synthon revealed that the two companies had entered into a global licensing agreement for its biosimilar version of Roche’s HER2-positive breast cancer treatment Herceptin (trastuzumab). "The agreement jumpstarts Amgen and Watson’s franchise," said Kate Keeping, associate director at BioTrends Research Group.

Validation of Synthon/other early-stage biosimilar developers

"The move is positive for Synthon, who have been looking for a partner,” Duncan Emerton – biosimilars practice lead at Datamonitor Consulting – told FirstWord, adding that “it validates both the company and the compound." There has been little visibility in terms of the clinical data for Synthon’s trastuzumab product, but any doubts are likely to be swept away by the investment from Amgen and Watson. Perhaps more importantly, the deal sends out a message; "small biotech and early-stage biosimilar companies will be looking at this and thinking ‘if we do a good job through to Phase I, big companies will look to partner and invest,’" says Emerton.

"It looks like a good tie-in", Keeping told FirstWord, "our surveys suggest the most trusted biosimilar companies will be those with prior biologic manufacturing experience like Synthon, while larger generic companies such as Watson will also be highly regarded."

The biosimilar Herceptin market

According to Emerton, there are approximately 20 biosimilar Herceptin projects in development, although the majority of these are being readied for commercialisation in emerging markets. "Insofar as the lack of competition in the developed markets, Herceptin is a good choice of product to pursue," he says. Synthon notes on its website that the product is one of the first trastuzumab biosimilars to complete Phase I testing in Europe. "It’s also a strong target in terms of intellectual property," adds Emerton; Herceptin patent expiry in the EU is expected to occur in 2014.

There is a strong chance that Amgen and Watson will not be first to market, however, even in the developed markets. The South Korean company Celltrion, which has already filed its biosimilar version of Remicade (infliximab) in the EU, could be ready to file its biosimilar version of Herceptin by the end of 2012, says Keeping. See also ViewPoints: EULAR presentation should provide launch pad for first biosimilar MAb approval.

The choice of product is also significant, as it illustrates overcrowding in the biosimilar Rituxan market, adds Emerton, reiterating the view that product selection has become increasingly strategic within the biosimilar space. See also Spotlight On: The diminishing value of biosimilar investment.

Roche’s defence strategy

Competition faced by Amgen and Watson will not be limited to rival biosimilar developers. "Roche has vowed to keep its patients," notes Emerton, citing the launch of pertuzumab, the development of subcutaneous Herceptin and development of its conjugate antibody T-DM1. “Not only does Roche have the best biosimilar defence strategy but it is willing to play the price game in certain markets," as evidenced by recent moves in India and South Africa. "Roche will be a formidable competitor,” suggests Emerton. See ViewPoints: Roche continues re-pricing strategy for antibody products in emerging markets.

Outlook

Confirmation of its pursuit to develop biosimilar Herceptin marks a turning point for the biosimilars market but more significantly for Amgen – the world’s largest standalone biologics company (its closest rival of course being Roche’s Genentech unit – the developer of Herceptin). Driven by its success in the epoetin space, Amgen has grown to Big Pharma scale; however the headwinds it faces over the next few years – ironically, due to biosimilar competition – also appear familiar to the Big Pharma template. Despite the challenges it faces in development, biosimilars are likely to "provide welcome profit" for Amgen, says Emerton.

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