Increasing impact of biosimilars on the market of originator therapeutic antibodies

STUTTGART, Germany I May 29, 2016 I 2015 was the last year without significant impact of biosimilars on the world of branded originator therapeutic antibodies in regulated markets. The targets of the first wave of biosimilar antibodies are the three anti-TNF antibodies Humira, Enbrel and Remicade and the cancer antibodies Herceptin, Avastin, Rituxan (MabThera) and Erbitux. Together, these seven therapeutic antibodies generated worldwide sales of US$ 53.5 mln in the year 2015, with six of them ranking among the TOP 10 blockbuster biologics.

European regulation paved the way for development and approval of biosimilar therapeutic antibodies in all indications of the reference products. The US FDA followed slowlier, but recently approved a biosimilar version of Remicade which Pfizer plans to launch in the US still in 2016. Sales of biosimilar antibodies in the European Union started in early 2015 with a Remicade biosimilar followed by an Enbrel biosimilar version, developed by Korean companies Samsung Bioepis and Celltrion. First sales data indicate that originator and biosimilar anti-TNF antibodies mainly compete for new patients due to the price difference, while prescribers so far were reluctant to switch from originator to biosimilar antibodies in patients under ongoing treatment.

While the commercial impact of biosimilar anti-TNF antibodies in the year 2015 still was controlled, sales data of the first quarter of 2016 show a 30% loss of Remicade sales in Europe (about US$ 150 mln). However, the major target of biosimilar attack is AbbVie’s Humira with 2015 sales of US$ 14.4 bln. Based on patent expiry in late 2018 in the European Union, AbbVie expects only moderate erosion of sales outside the US from direct competition beginning in 2019. AbbVie’s defense strategy in the US intends to make use of a plethora of patents covering methods of treatment, formulation, manufacturing and combination with devices or diagnostics with earliest expiry in 2022, while the composition of matter Humira patent in the US is going to expire in December 2016.

However, a cornerstone patent in AbbVie’s defense strategy, i.e. protecting the bi-weekly dosing of Humira for rheumatoid arthritis (US patent 8,889,135, the „135 patent“), is going to be challenged and reviewed by the Patent Trial and Appeal Board of the US Patent and Trademark office, which ultimately could lead to accelerated loss of Humira market exclusivity, with biosimilar Humira versions entering the US market in 2019 or 2020.

More than 20 different biosimilar anti-TNF antibodies are in phase III development following EU and US guidelines, as described in a Competitive Intelligence report about Biosimilar and Biosuperior Therapeutic Antibodies – 2016 Update released by La Merie Publishing. The report updates the competitive landscape of biosimilar therapeutic antibodies as of May 2016. The report evaluates the the first wave of biosimilar recombinant monoclonal antibodies in comparison with the corresponding originator antibodies and biosuperior antibodies against the same target. The report also describes the next wave of potential biosimilar versions of therapeutic antibodies loosing patent protection in the time frame of 2019 – 2023. The report specifically lists for each target the branded products with their 2015 sales and up-side indications in development, as well as biosuperior and biosimilar antibody drug candidates in development.

The report includes a compilation of marketed, approved and currently active projects in research and development of biosimilar and biosuperior therapeutic antibodies against commercially and clinically validated targets relevant for the first wave of biosimilar antibodies (VEGF, TNF, Her2, CD20, EGF-R). Relevant first wave originator therapeutic antibodies are Humira, Enbrel, Remicade, Avastin, Lucentis, Eylea, Herceptin, Rituxan / MabThera and Erbitux. Second generation therapeutic antibodies against these targets such as Symponi, Cimzia, Cyramza, Perjeta, Arrzera are also subject of biosimilar activities.

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SOURCE: La Merie Publishing