The long awaited promise of biosimilars takes another step to fulfilment with the first approval in Europe of high-value second generation products. But what products can be expected to follow, who is developing them and what are the hot prospects?
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Biosimilars: another milestone passed
At the end of June 2013, the European Medicines Agency’s Committee for Medical Products for Human Use issued a positive opinion for the first biosimilar version of Johnson & Johnson’s infliximab for the treatment of rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. For the two successful applicants, Celltrion and Hospira, this development passes a significant milestone for the whole biosimilar sector as the products are the first monoclonal antibody (mAb) therapies to reach a positive opinion following review via the EMA biosimilars regulatory pathway. This is an important event which heralds a new era of lower-cost biological therapies in Europe.
For J&J and its partners, the news is less welcome. Already under pressure from branded competitors in the TNF inhibitor market, it is no surprise that both developer and biosimilar companies will be assessing what share they may secure of its US$6.13 billion revenues.
The tip of a US$41 billion iceberg
While significant for J&J, infliximab is just the tip of the iceberg when it comes to the potential for biosimilars. In terms of revenue, six of the top ten pharmaceutical therapies are biological products, which have been targeted by biosimilar developers: Abbvie’s Humira (adalimumab), Roche’s MabThera (rituximab), Herceptin (trastuzumab) and Avastin (bevacizumab), Sanofi’s Lantus (insulin glargine), and Johnson & Johnson’s Remicade (infliximab). These products had combined global sales of US$41.4 billion in 2012. Also of significant importance to biosimilar developers, with sales of US$4.2 billion in 2012 is Amgen’s Enbrel (etanercept).
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Open season: Branded industry gets in on the act It may have taken a while, but the world’s major pharmaceutical originators have recognised the potential for biosimilars. A number have disclosed their intentions and/or announced clinical trials in recent months. For example, in February 2013, Amgen announced plans to launch a portfolio of six new biosimilars beginning in 2017: adalimumab, infliximab, bevacizumab, trastuzumab, rituximab and cetuximab. Four of these projects form part of the company’s development agreement with Actavis. In June 2012, Merck KGaA and Dr Reddy's Laboratories announced a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies. Pfizer has been openly active in generics and biosimilars for some time. The company previously had a collaborative deal with Biocon for its insulin products, although this deal was concluded in March 2012. In May 2013, Pfizer began a Phase I trial with an infliximab biosimilar, PF-06438179. Many smaller biosimilar developers have the ambition but not the resources. The increasing interest from big Pharma will bring a welcome boost of expertise and funding to research and partnering.
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