Samsung Bioepis' Bevacizumab Biosimilar Gets CHMP Nod

Samsung Bioepis said the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company’s bevacizumab biosimilar (Aybintio).

The drug, which references Genentech’s Avastin, would be used for the treatment of metastatic carcinoma of the colon or rectum; metastatic breast cancer; non—small cell lung cancer; advanced or metastatic renal cell cancer; epithelial ovarian, fallopian tube, and primary peritoneal cancer; and cervical cancer.

The positive CHMP opinion will be reviewed by the European Commission, which will decide on the marketing approval for Aybintio.

“Once approved, Aybintio will be a valuable treatment option for different types of cancers, potentially helping many patients across Europe,” said Hee Kyung Kim, senior vice president of clinical science and regulatory affairs at Samsung Bioepis, in a statement.

CHMP gave a positive opinion following a review of pharmacokinetic and pharmacodynamic data demonstrating that Aybintio was highly similar to the reference product and had no clinically meaningful differences.

In the United States, Samsung Bioepis submitted a biologics license application for Aybintio in 2019 and the biosimilar candidate remains under review by the FDA.

Samsung Bioepis Pipeline

The company, based in Incheon, Republic of Korea, has 4 other biosimilars approved in Europe: Eticovo, an etanercept biosimilar; Renflexis, infliximab; Hadlima, adalimumab; and Ontruzant, trastuzumab. All 4 of those products are also approved in the United States, Republic of Korea, and Australia.

In 2019, Ontruzant became the first biosimilar to be prequalified by the World Health Organization (WHO). The WHO designation helps to guide many low- and middle-income countries in selecting medicines for use and may encourage biosimilar use, which could drive down drug prices.

Samsung Bioepis is also developing 4 other biosimilars, with Aybintio being the furthest along and the only one in the filing stage.

Both their ranibizumab (SB11) and eculizumab (SB12) biosimilars have completed phase 3 clinical trials. Their biosimilar aflibercept is currently in preclinical trials.

Commercialization Deals

In November 2019, Samsung Bioepis announced that it would enter into a commercialization agreement with Biogen for its ranibizumab and aflibercept biosimilars. The agreement woud cover marketing in the United States, Canada, Europe, Japan, and Australia.

The deal also allowed Biogen to receive commercialization rights for 3 anti—tumor necrosis factor agents in China in exchange for sales royalties.

In 2013, Samsung Bioepis entered into a development and commercialization agreement with Merck for a follow-on insulin glargine product, but patent infringement litigations from reference product developer Sanofi forced the companies to terminate the agreement in 2018.