PHARMACY

Amgen, Abbvie settlement sets stage for Humira biosimilar launch in 2023

BY David Salazar

THOUSAND OAKS, Calif. — Humira manufacturer AbbVie and Amgen, maker of Humira biosimilar Amjevita (sometimes spelled Amgevita), have reached a settlement that will allow the biosimilar to launch — but not for several years. The settlement will see AbbVie granting Amgen a non-exclusive license to its Humira intellectual property on certain dates in certain countries, with the license period set to begin on Jan. 31, 2023.

Also under the agreement, Amgen will pay undisclosed royalties to AbbVie. As a result of the settlement, all litigation between the two companies has been dismissed, with Amgen acknowledging the validity of AbbVie’s intellectual property relating to Humira.

“We look forward to leveraging our existing biologics capabilities to bring high-quality biosimilars to patients worldwide. Amgevita will be one of our first biosimilar launches, and this agreement will allow us to secure a strong foothold in the $4 billion European adalimumab market," Amgen VP and GM biosimilars Scott Foraker said “Building on our strong inflammatory disease presence in the United States, we are excited to develop our inflammation capabilities in Europe, extending our reach and helping more patients gain access to this important class of therapies.”

AbbVie EVP external affairs, general counsel and corporate secretary Laura Schumacher said, “We are pleased to have reached this settlement with Amgen which respects the breadth and strength of our intellectual property portfolio. … In reaching this agreement, we have achieved the balance between protecting investment in innovation and providing access to biosimilars, which will play an important role in our health care system. We will continue to defend our intellectual property and to reinvest in further advancements in medicine to bring choices to patients in need.”

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Amneal intros generic Minsatrin 24 Fe

BY David Salazar

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has added its eighth oral contraceptive to its women’s health portfolio. The company has launched Melodetta 24 Fe, its generic of Minastrin 24 Fe ((norethindrone acetate and ethinyl estradiol, 1 mg/20 mcg).

The drug had U.S. sales of approximately $350 million for the 12 months ending July 2017, according to QuintilesIMS data. The product will be manufactured at the company’s newly expanded Brookhaven, N.Y., production facility.

 

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FDA approves Lilly’s breast cancer drug Verzenio

BY David Salazar

SILVER SPRING, Md. — Eli Lilly’s new treatment for certain breast cancers has been approved by the Food and Drug Administration. Verzenio (abemaciclib) was approved to as a treatment for patients with a hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that is advanced or metastatic and has progressed following endocrine therapy.

"Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a standalone treatment to patients who were previously treated with endocrine therapy and chemotherapy," said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Verzenio works by blocking certain molecules that are involved in cancer cell growth. It joins two previously approved drugs in this class — palbociclib (Pfizer’s Ibrance) and ribociclib (Novartis’ Kisqali). The National Cancer Institute and the National Institutes of Health estimate that roughly 252,710 people will be diagnosed with breast cancer this year. Approximately 72% of patients have breast cancer with tumors that fit the criteria for treatment with drugs like Verzenio. 

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