Mylan lands biosimilar sucker punch to Amgen’s blockbuster

Mylan and Biocon have received FDA approval for their biosimilar to Amgen’s Neulasta (pegfilgrastim), setting the companies on track to snatch a chunk of the treatment’s $4.2 billion per year in sales, as recorded last year.

The approval marks a major success for Mylan, which has suffered from a serious dip in the US generics market. It has, alongside other players in the market, such as Sandoz, pivoted towards biosimilars as a mean of boosting future sales.

In this case, the gamble has paid off – though the two companies involved hit a rocky patch, after the FDA delivered a CRL to Biocon over mistakes at its India-based plant in October of last year.

The treatment itself ensures that patients who have received chemotherapy do not lose too many white bloods cells and has become a core part of Amgen’s portfolio, which will now suffer precipitous drop-off in sales.

Analysts predict that the biosimilar, named Fulphila, should be able to reap sales of around $100 million in the first year and to accrue a 20% to 25% share of the market.

To make these figures stack up, Mylan will have to price the drug significantly lower than Neulasta’s current price point, and Dolat Capital expects it to pitch the drug somewhere between 20% and 25% lower.

Mylan CEO, Heather Bresch, commented, "I couldn't be prouder of this approval for Fulphila, the first alternative option for pegfilgrastim approved in the US, as it represents an important milestone for patients and further demonstrates Mylan's continued fight to expand access to medicine. FDA's approval of this product, as well as the agency's continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients."

Mylan has revealed that it will be ready for commercial launch of its products within weeks of its approval and its shares reacted positively, rising by close to 4% on release of the news.

Biocon’s shares also bounced 6% higher, to a record high, before levelling off. The successful development of their second biosimilar and, with a further nine other products being co-developed, both will be hoping it could be the first of many such launches.

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