by Richard Staines
LONDON, Oct 14 (APM) - Amgen has said it is gearing up for a launch of its biosimilar portfolio, including its version of AbbVie's big-selling monoclonal antibody Humira (adalimumab) from 2017, the year after the anti-inflammatory drug's U.S. patent expires.
In a brief emailed interview to APM late last week, Amgen said it planned to launch its portfolio of six biosimilar monoclonal antibodies, Humira (adalimumab), Johnson & Johnson/MSD's Remicade (infliximab), Roche's Herceptin (trastuzumab), Avastin (bevacizumab), Rituxan/MabThera (rituximab), and Merck KGaA's Erbitux (cetuximab) from 2017 onwards.
Amgen last week announced positive Phase III results for its ABP 501 biosimilar of Humira in plaque psoriasis (APMMA 40009), putting it in competition with companies such as Sandoz (APMMA 36651) that are attempting to produce near-copies of the drug that generated sales $3.3 billion in Q2 alone.
An Amgen spokesperson told APM: “Specific filing dates for ABP 501 are not currently available. However, we expect to launch our biosimilars portfolio beginning in 2017.
“We were pleased with the read out of our Phase III study evaluating efficacy and safety of biosimilar candidate ABP 501 compared with Humira in patients with moderate to severe plaque psoriasis. The results are an exciting step towards expanding patient access.”
The U.S. firm said it aimed to use a partnership with Actavis, along with existing biologics R&D experience, manufacturing and supply base to gain market share in a highly competitive biosimilars market as more monoclonal antibody near-copies are approved by regulators.
Amgen did not indicate whether it planned to use a regulatory approach that would allow it to use one reference molecule for the EU and U.S., potentially saving the number of trials needed for approval in these two key markets.
“Amgen’s development programmes are designed to satisfy the multiple stakeholders globally, including the different health authorities in each country or region,” the spokesperson said.
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