I should add “and yours truly” to the title of this post, having been lucky enough to work with several companies, either active in biosimilar development or having a biologics franchise at risk from biosimilar competition (both in some cases).
Biosimilars, functionally identical versions of complex biologic medicines such as human growth hormone, colony stimulating factor and erythropoietin were first launched in ex-US markets almost a decade ago, largely with modest impact on originator product sales. Regulatory approval of biosimilar versions of high earning biologics indicated in autoimmune disease treatment has dramatically changed the landscape by threatening key multi-billion dollar earners: Humira® (adalimumab: AbbVie); Enbrel® (etanercept: Amgen/Pfizer) and Remicade® (infliximab: J&J/MSD).
Remicade® lost patent protection in the larger European markets in February 2015 and faced immediate competition from an infliximab biosimilar developed by Celltrion, a South Korean company, (confusingly marketed as two brands, Inflectra® and Remsima®) and which had gained traction in “early adopter” countries such as Norway and Denmark due to its unexpectedly high discount to Remicade®. J&J posted a 20% decrease in Remicade® revenue for 2015.
A biosimilar version of Enbrel® (Benepali®: Biogen) approved in Europe just over a year ago is set to to at least match the uptake of biosimilar infliximab. Humira®, with global sales of close to $16 billion, is under threat from a slew of heavyweight pharma and biopharma companies developing adalimumab biosimilars.
Given the potential for cost-saving, it’s no surprise that healthcare systems are keen to take advantage of biosimilars. In Europe, national authorities have taken a pragmatic view of biosimilar interchangeabilty, with gradual lessening of prescriber issues over extrapolation of use into indications not included in registration studies. US biosimilar guidelines are under development but four FDA approvals in 2016 have signalled that there are no inherent barriers to regulatory success. Lower acquisition cost should (eventually) translate into more patients receiving biologics therapy with neutral impact on expenditure by public and private payers.
It’s also hardly surprising that, faced with a significant hit to hard-to-replace established franchises, J&J, Amgen and AbbVie are fighting an intense rearguard action in the US and UK courts to delay biosimilar entry. J&J have, so far, lucked out to Pfizer in the US, with the latter launching Celltrion’s infliximab biosimilar in November 2016 after overturning a patent challenge. Amgen’s lawyers have successfully delayed the entry of Novartis’s biosimilar version of Enbrel® until at least late 2018.
AbbVie is fighting multiple challenges from Amgen, Boehringer Ingelheim and others in the US with the expectation that biosimilar market entry can be delayed until at least 2023 (the core Humira® patent expired in the US in December 2016). Biogen/Samsung Bioepsis and Fujifilm Kyowa Kirin Biologics have challenged AbbVie in the UK courts to ensure a clear runway after European patent expiry in October 2018.
AbbVie’s broad portfolio of granted and pending Humira® patent applications makes for a tough nut to crack, but it’s an indicator of just how far biosimilars have matured in that lawyers and judges, and not regulatory authorities, will now dictate the path to successful biosimilar commercialisation. Patent lawyers are likely to do equally well in the near future as biosimilar versions of the best selling biologic cancer treatments, Herceptin®, Avastin® and Rituximab/MabThera® win regulatory approval.
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