EU’s CHMP Expected To OK Another Biosimilar Humira
Executive Summary
The European Medicines Agency’s CHMP is expected to give the green light to Samsung Bioepis’ biosimilar version of AbbVie’s anti-TNF-alpha Humira on June 23. Numerous other biosimilar developers have biosimilar adalimumabs under development in a bid to break into the $16bn market for the world’s top-selling drug.
On June 23, following its monthly meeting this week, the European Medicines Agency’s scientific committee, the CHMP, is expected to recommend approval of another biosimilar version of AbbVie Inc.’s blockbuster TNF-alpha inhibitor, Humira (adalimumab).
This is most likely to be Samsung Bioepis Co. Ltd.’s SB5, which was accepted for filing by the EMA just under a year ago, in July 2016. If it is OKd by the CHMP and then approved by the European Commission, the product will be set to take a slice of the $16bn global market for Humira, the world’s top-selling drug.
At the time of filing, the company said that the EU marketing authorization application was based on results of a 52-week Phase III study which randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy and showed SB5’s comparable efficacy and safety to Humira among different treatment groups.
Samsung Bioepis’ commercialization partner, Biogen, will handle European marketing and distribution of SB5, which will be the South Korean company’s third anti-TNF-alpha biosimilar to reach the European market. The others are Benepali (a version of Amgen Inc.’s Enbrel/etanercept) and Flixabi (Janssen Inc.’s Remicade/infliximab), which were both approved in the EU last year (in January and May respectively).
Other Potential Humira Competitors
Understandably enough, Humira is a key target for many biosimilar developers. Already the best-selling pharmaceutical product, its global sales rose by 15% to just over $16bn in 2016, accounting for 63% of the company’s revenues. $10.4bn of the sales were in the US, and $5.6bn in the rest of the world. In the first quarter of 2017, its sales rose by 15% to $4.1bn.
Amgen was the first to gain an EU approval for biosimilar adalimumab when its products Amgevita and Solymbic were authorized for marketing by the European Commission in March this year.
Other biosimilars are under evaluation by the CHMP too, although they are further back in the queue. Boehringer Ingelheim GMBH‘s biosimilar adalimumab (BI 695501) was filed with the EMA and the US FDA in January this year, and the company presented pivotal Phase III results with the drug at the recent Annual European Congress of Rheumatology (EULAR) in Madrid, Spain. (Also see "Boehringer Ingelheim Limbering Up With Humira Biosimilar" - Scrip, 14 Jun, 2017.)
Sandoz Inc.’s adalimumab biosimilar (GP2017) was accepted for filing by the EMA in May (Also see "Sandoz Files Biosimilar Humira & Remicade In EU; 13 Products Now Under Evaluation By CHMP" - Pink Sheet, 31 May, 2017.), as was Fujifilm Kyowa Kirin Biologics Co. Ltd.’s FKB327; the Japanese company also presented its Phase III results at the EULAR 2017 conference.
However, breaking into the Humira franchise in Europe may not be that straightforward: while Humira’s main European patent expires in the fourth quarter of 2018, it also has a number of other patents on the drug.
Two dosage patents were invalidated by the English Patents Court in March, in a case brought by Samsung Bioepis and FKB, which were trying to clear the way for the launch of their products. The judge said the declarations would dispel the “commercial uncertainty” over whether the patents were valid in the UK and Europe, although the decision is not binding in any other countries. (Also see "Setback For AbbVie’s Humira As English Court Decision Clears Way For Biosimilars" - Pink Sheet, 8 Mar, 2017.)
In the US Amgen is unlikely to launch its version (as Amjevita) until at least 2018 because of the complexity and pace of ongoing patent litigation. (Also see "Biosimilar Launches Depend Mostly On Patents After Supreme Court Ruling" - Scrip, 13 Jun, 2017.)
Market Access Issues
Moreover, as with many new drugs these days, market access for biosimilars is a major challenge, with issues like lack of incentives for prescribers and price discounting on originators often proving a barrier to entry. While some biosimilars, such as infliximab, have taken high market shares in some EU countries, others have struggled to gain a foothold in the market.
Originator industry opposition to biosimilar switching has also played a part: most recently, for example, three pharmaceutical industry bodies issued a position paper advising doctors against switching patients among biosimilar versions of originator biologics on the grounds that the biosimilars will not have been assessed against each other. (Also see "Industry Bodies Warn Against Switching Among Biosimilars" - Pink Sheet, 10 Mar, 2017.)
Another barrier is the lack of guidance on biosimilar switching, although a number of European countries have developed policies on biosimilar use and backed switching provided certain conditions are met. Others, such as the UK, have followed multi-stakeholder approaches such as gainsharing agreements. (Also see "13 Ways To Create A Sustainable Biosimilars Market In Europe" - Pink Sheet, 28 Sep, 2016.)