AbbVie rules out joining the biosimilars bandwagon
pharmafile | November 17, 2015 | News story | Manufacturing and Production, Research and Development |
AbbVie says it has ruled out moving into the biosimilars market to stave off competition once its blockbuster drug Humira comes off patent.
In a session on biosimilars at the FT Global Pharmaceutical and Biotechnology conference in London, Perry Siatis, vice president of biologics strategic development at AbbVie, told delegates the company’s strategy would be to continue to push ‘innovative biologics’ to market and the US firm planned to shun biosimilars in it future strategy.
AbbVie has already ruled out following other companies lead by developing or acquiring biosimilars. Pfizer has invested heavily in biosimilars with its $15 billion acquisition of Hospira, while Lilly and Boehringer Ingelheim recently launched their biosimilar insulin glargine in the UK.
“AbbVie does not believe there’s enough robust evidence to support biosimilar switching, and a number of regulatory agencies around the whole have noted that fact. There is a meaningful risk of unintended immune reactions that comes with switching a patient who is stable on a biologic drug to a biosimilar version of that drug. It’s more than just a theoretical risk, and that is recognised by regulators.
AbbVie’s biologic drug Humira (adalimumab) has consistently been one of the world’s best-selling drugs, and in the first three quarters of 2015 it generated $10.3 billion in net revenues – nearly two-thirds of AbbVie’s total revenue. Sales of Humira increased by 12.1%, a major driver of the company’s 19.6% growth compared with the first nine months of 2014.
But Humira’s patent is set to expire at the end of 2016, leaving AbbVie at serious threat of biosimilar competition – and potential candidates are already gearing up to take on the
At the American College of Rheumatology conference Amgen presented Phase III trial results of its humira biosimilar, ABP 501, which found the biosimilar had comparable efficacy to Humira. After six months, 74.6% of patients in the ABP 501 group and 72.4% in the Humira group met the ACR20 response criteria. Amgen says it plans to submit ABP 501 for FDA approval by the end of 2015.
Merck and Samsung Bioepis reported positive Phase III data for a Humira copy in July and also plan global regulatory filings in the coming months. Novartis, Baxalta and Momenta Pharmaceuticals also have Humira biosimilars in the pipeline.
But Siatis maintains AbbVie will continue to invest in biologics, and not biosimilars, in the future. “We believe in developing and bringing to market innovative biologics and will continue to do so. Because of the risk that comes with switching we would not support a switching strategy, and at the moment we do not believe that regulators have the policies in place to be able to manage that risk.”
On the same panel SeungSuh ‘Stanley’ Hong, president and chief executive of South Korean biosimilars specialist Celltrion Healthcare, manufacturers of the two biosimilar versions of infliximab that are available in Europe – Remsima and Inflectra.
Lilian Anekwe
