Biosimilars Check-in: Approval in Saudi Arabia, Launch in Republic of Korea, Dr. Reddy’s Completes Study

Saudi Arabia approved an adalimumab biosimilar, a denosumab biosimilar entered the market in the Republic of Korea, and Dr. Reddy’s Laboratories announced the completion of a phase 3 study for its rituximab biosimilar.

An Adalimumab Approval in Saudi Arabia

Alvotech and Bioventure said that the Saudi Food & Drug Authority approved AVT02, an adalimumab biosimilar referencing Humira, for manufacturing and distribution throughout Saudi Arabia, according to a report from Seeking Alpha.

The drug has received indications for rheumatoid arthritis as well as several other inflammatory diseases, such as psoriasis and inflammatory bowel disease. In Saudi Arabia, the biosimilar will be marketed under the name Simlandi.

AVT02 is the first biosimilar under Alvotech and Bioventure’s strategic partnership to receive regulatory approval in Saudi Arabia. As part of the agreement, Alvotech will be responsible for development and manufacturing and Bioventure will be in charge of marketing and distribution.

“We look forward to bringing this essential treatment to patients in Saudi Arabia as well as other key markets in the Middle East and North Africa," said Ashraf Radwan, Division CEO of GHH, Bioventure’s parent company.

AVT02 has also been approved by the European Medicines Agency and Health Canada. It is currently under review with the US FDA, with a manufacturing facility inspection scheduled for March 6, 2023 and a decision date of April 13, 2023.

Republic of Korea Welcomes a Denosumab Biosimilar

A report from Korea Biomedical Review said HK inno.N entered into an exclusive license agreement with mAbxience for a denosumab biosimilar referencing Prolia/Xgeva for the Republic of Korea market.

The biosimilar will be used to treat and prevent osteoporosis and cancer-related skeletal complications. Under the agreement, HK inno.N will hold the marketing rights for a 60 mg version of the biosimilar and a 120 mg version. mAbxience will be responsible for obtaining domestic approval and proceeding with sales.

“Due to excellent efficacy and convenience, the market for denosumab is steadily growing…. Through the introduction of biosimilars, we will provide new treatment options for osteoporosis patients and cancer patients suffering from skeletal complications,” said Kwak Dal-won, CEO of HK inno.N.

Dr. Reddy’s Announced Rituximab Progress

Dr. Reddy’s Laboratories, a Hyderabad, India-based company, shared that it had successfully completed the full set of clinical studies needed to obtain approval for its rituximab biosimilar candidate (DRL_RI). The company said that it plans to submit to the FDA and the European Medicines Agency as well as regulatory authorities in other regions.

DRL_RI references Rituxan, a cluster of differentiation 20 directed cytolytic antibody used in the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

The biosimilar is already approved in India and over 25 other emerging markets. The company conducted additional clinical development processes to meet the regulatory requirements of the United States, the European Union, and other highly regulated markets.

“This is a very important milestone in our biosimilars journey. The successful completion and positive outcome of these clinical studies highlights our capability for global clinical development of biosimilar products for highly regulated and global markets. These results underscore our commitment to developing high quality biosimilars and reinforce the potential of DRL_RI as a safe and effective treatment option to patients across the globe,” said Jayanth Sridhar, PhD, global head of biologics at Dr. Reddy’s.

Dr. Reddy’s is in the process of collaborating with its partner Fresenius Kabi for the commercialization of DRI_RI in the United States.