According to an article recently published by GEN, out of the listed innovator drugs that have biosimilar developers hot on their heels, five of these are therapeutic monoclonal antibodies. With the first mAb biosimilar approved in Korea, and mAb biosimilar marketing authorisation applications currently with the EMA, the development of this class of biosimilars is certainly one to watch.
So which mAb therapies are those being copied at present?
Herceptin (trastuzumab) – With an EU patent to expire in 2014, and a US patent to expire in 2019, Roche could very well soon lose a share of its blockbuster drug that bought in US$6.317 billion in 2012 sales. Amongst those developing biosimilars to this mAb are Actavis, BioXpress, Hanwha Chemical, Pfizer, PlantForm and Stada Arzeimittel. Data suggest that Actavis has the most developed Herceptin biosimilar at this stage.
Humira (adalimumab) – AbbVie's blockbuster bought in US$9.265 billion in 2012 sales, and faces patent expiry in 2018 in the EU and 2016 in the US. Those developing Humira biosimilars include AET BioTech/BioXpress, Amgen, Boehringer Inelheim and Fujifilm Kyowa Kirin Biologics.
Remicade (infliximab) – yielding US$8.215 billion on 2012 sales (split between Johnson & Johnson and Merck &Co), The Remicade patent is set to expire in 2014 in the EU and 2018 in the US. With Celltrion's Remsima biosimilar already authorised in Korea and seeking marketing authorisation in the EU, could this be the first biosimilar mAb product to hit the EU market? Aside from Celltrion's biosimilar, Amgen and BioXpress are also actively developing infliximab biosimilars.
Rituxan/MabThera (rituximab) – the number of biosimilar developers here is perhaps reflective of the short amount of time until this patent expires in the EU – the EU patent is set to expire in 2013, and US patent set to expire in 2018. Amongst those hoping to capitalise on the loss of exclusivity of this drug in the EU are Amgen, BioXpress, Boehringer Ingelheim, Celltrion/Hospira, Dr Reddy's Laboratory, iBio, Merck, Pfizer, Probiomed, Roche, Sandoz and Stada Arzneimittel/Gedeon Richter.
Avastin (bevacizumab) – Although patent protection extending much longer with this mAb (EU patent expiry in 2019 in the US and 2022 in EU), Amgen and Fujifilm Kyowa Kirin Biologics have already announced plans to develop a biosimilar for this product.
If you want to know more about biosimilars (and particularly mAb biosimilars) you might be interested in attending the World Biosimilar Congress 2013. Or if you're interested in antibodies, this event is also co-located with the European Antibody Congress 2013. Both these events are taking place in Geneva this November.
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