January 19, 2023
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Amgen seeks European OK of biosimilar drug, partners with Merck on studies


Amgen co-founder William K. Bowes Jr. stands watch over the Thousand Oaks campus.

Amgen co-founder William K. Bowes Jr. stands watch over the Thousand Oaks campus.

Amgen announced two developments Dec. 4 that should help the Thousand Oaks-based biotech giant compete.

Amgen said it is seeking approval from the European Medicines Agency for ABP 501, a biosimilar drug similar to Humira. Amgen also announced a partnership with New Jersey-based pharmaceutical Merck to partner in a non-Hodgkins lymphoma study using drugs from both companies.

ABP 501 is Amgen’s biosimilar drug that mimics the effects of Humira. Amgen submitted the application to the Europeans a week after submitting an application for the same drug to the U.S. Food and Drug Administration.

The drug is part of a new class of medicines called biosimilars, which are similar to generics but are made with living organisms and are not identical to the complex compounds they replicate.

Humira, made by Chicago-based AbbVie, had sales of $12.54 billion in 2014 and $3.65 billion during the third quarter of this year. ABP 501 is designed as a lower-cost version of Humira, which is approved to treat nine conditions including rheumatoid arthritis, skin disorders and colon inflammation. Humira typically costs $20,000 per year for treatments.

The main patents protecting Humira expire at the end of 2016, however AbbVie is fighting tooth and nail to prevent drugs similar to Humira from hitting the market before 2020.

“The submission of Amgen’s first biosimilar application to the EMA is an exciting milestone as we seek to expand our global patient reach,” said Sean Harper, executive vice president of research and development at Amgen in a news release.

Amgen also announced two partnerships with Merck.

The first will study non-Hodgkin’s lymphoma patients who will take a combination of Amgen’s Blincyto and Merck’s Keytruda. Blincyto is a drug designed to treat acute lymphoblastic leukemia, which has few treatment options once a patient has relapsed. Just two courses of Blincyto treatments cost around $178,000.

Keytruda is a human anti-body that interferes with the growth and spread of cancer developed by Merck. The drug is predominantly used to treat serious cases of skin cancer and certain types of lung-cancers.

The companies also announced a study using a combination of Keytruda and AMG 820, which is another of Amgen’s cancer fighting immunotherapies. That study is designed for patients with certain advanced solid tumors.

“The combination of therapies is an important approach for overcoming the ever-changing and complex nature of many cancers,” said Eric Rubin, vice president and therapeutic area head of oncology early-stage development at Merck Research Laboratories. “The combination of these immunotherapies may hold potential for patients with cancer and we look forward to partnering with Amgen to advance these trials with the hope of bringing forward new treatment combinations for patients with various types of cancer.”

• Contact Philip Joens at pjoens@pacbiztimes.com.