Companies fight to launch biosimilars amid expiries

In April, the Food and Drug Administration granted approval to Pfizer’s Inflectra (infliximab) — a biosimilar of Janssen’s Remicade and possibly the second biosimilar to be launched in the United States. But like the first biosimilar, Zarxio (filgrastim-sndz), Inflectra is subject to a 180-day waiting period before launch, and is currently facing opposition from Janssen, which claims Remicade’s patent doesn’t expire until 2018.

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Despite the challenges, Pfizer has said it is planning a 2016 launch for this treatment for rheumatoid arthritis and plaque psoriasis. If it came to pass, Inflectra’s introduction would be one of two biosimilar launches this year. Approved in January, Boehringer Ingelheim and Eli Lilly & Co.’s Basalgar (insulin glargine), a “follow on” biologic to Sanofi’s Lantus insulin — which saw $5.8 billion in sales in 2015 — is expected to launch after December 15.



As some companies prepare to market their biosimilars, others are still in development.



The highest-selling drug currently awaiting an FDA decision is Amgen’s ABP 501, a biosimilar of AbbVie’s Humira, which treats, among other conditions, plaque psoriasis and Crohn’s disease. The drug saw the second-most nondiscounted drug spending in 2015, pulling in $10.6 billion dollars — an increase of nearly 35.9% over its 2014 sales. In July, an FDA panel unanimously recommended ABP 501’s approval.



And Amgen certainly isn’t alone. At the end of 2015, the IMS Institute noted that there were five biosimilars in the pre-registration phase of development, in addition to the since-approved Inflectra. Among the pre-registration products were two biosimilars for Neulasta (pegfilgrastim), which treats neutropenia and had $4.1 billion in 2015 sales, as well as one each for Enbrel (etanercept), Avastin (bevacizumab), Amgen’s Humira biosimilar, and another Neupogen (filgrastim) biosimilar.