Biosimilars Check-In: Canada Approves Third Etanercept; Prestige Withdraws Trastuzumab Application

Outside of the United States, 2 companies shared news regarding the progress, or lack thereof, of their respective biosimilars, with 1 announcing an approval and another experiencing a setback.

Canadian Approval of Etanercept Biosimilar

Health Canada has approved Rymti, an etanercept biosimilar developed by Lupin Limited, for use in patients with rheumatic conditions across Canada. The announcement from Lupin Limited marked the third biosimilar referencing blockbuster drug Enbrel to be approved in the country.

Etanercept is an injectable tumor necrosis factor inhibitor used in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and plaque psoriasis in adults and children.

“Lupin is committed to enhancing patient access to high-quality, life-enhancing biosimilars…. The approval for Rymti in Canada is a key milestone in our endeavors to improving access to medicines. It underscores the scientific success of Lupin’s biosimilar programs and our commitment to advancing healthcare through innovation,” said Cyrus Karkaria, PhD, president of Lupin Limited’s biotech division.

Rymti follows in the footsteps of Brenzys and Erelzi, which were approved in August 2016 and April 2017, respectively. Additionally, there are 3 etanercept biosimilars approved in the European Union, 2 in the United States, and 5 in Brazil.

Prestige Biopharma Pulls European Application for Tuznue

Singapore-based Prestige Biopharma announced that it has withdrawn its application for marketing authorization for its trastuzumab biosimilar (Tuznue; HD201) that was submitted to the European Medicines Agency.

In May 2022, Prestige asked for their marketing authorization application (MAA) to be re-examined for Tuznue after it received a negative opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Despite its clinical trial data showing comparability and biosimilarity between the biosimilar and reference product (Herceptin), the CHMP gave a negative opinion because there was “disparity in the range of acceptance for the criteria of analytical comparability between the clinical testing batch and commercial production batch of HD201.”

During the re-examination period, a newly assigned main rapporteur gave a positive opinion but it could not overturn the CHMP’s range of acceptance for the analytical comparability criteria. Prestige voluntarily withdrew its MAA and said that it plans to reapply to EMA with supplemented data through more clinical testing and analysis to meet CHMP’s criteria.

Currently, applications for HD201 are under review by Health Canada and the Korea Ministry of Food and Drug Safety. Prestige said that plans to submit a biologics license application for the biosimilar to the FDA by the end of 2022.

Trastuzumab is used in the treatment of human epidermal growth factor 2-positive breast cancer and metastatic gastric cancer. As of September 2022, there are 6 EMA-authorized trastuzumab biosimilars (Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera, Zercepac).

Prestige’s internal and external expert advisory board panel commented, “The company’s confidence is based on the excellent pharmaceutical quality of HD201 proven through clinical studies and multiple analysis. Through the re-examination, we received positive opinion by the main rapporteur, which is encouraging. We will do our best to obtain approval for HD201 in US and Europe without any doubt and provide patients with better access to treatments.”