Coherus Secures Ranibizumab Biosimilar; Celltrion to Launch 1 Product Per Year; Bio-Thera Gaines Chinese Approval; Alvotech Forms Partnership

This week, multiple biosimilar developers announced major moves forward for their businesses, with Coherus BioSciences making a new acquisition, Celltrion reporting continued growth for its business, Bio-Thera Solutions gaining the first-ever approval of an adalimumab biosimilar from China’s National Medical Products Administration, and Alvotech and Stada entering into a 7-biosimilar partnership in Europe.

Coherus Secures a Ranibizumab Biosimilar From Bioeq

On Wednesday, Coherus BioSciences announced that it has acquired exclusive rights to Bioeq IP’s ranibizumab biosimilar, referencing Lucentis. According to a statement, Bioeq plans to file a Biologics License Application for the biosimilar this quarter, and Coherus plans to launch the biosimilar in 2021.

“This is the leading Lucentis biosimilar product candidate, and this license pulls forward our previously anticipated Lucentis biosimilar launch in the US by approximately [2] years,” said Denny Lanfear, president and chief executive officer of Coherus. “We are extremely impressed with Bioeq’s development of this molecule, which included a successful phase 3 study in wet age-related macular degeneration and robust molecular similarity data.”

Bioeq announced in 2018 that the biosimilar had met its primary efficacy end point—change in best corrected visual acuity after 8 weeks—in its phase 3 trial, and the study did not raise any new concerns about safety or immunogenicity.

Under the terms of the deal, Coherus will make an upfront payment to Bioeq and will also make regulatory and launch milestone payments. The companies will share profits on the eventual drug.

Coherus also announced results for its pegfilgrastim biosimilar, Udenyca, in its third quarter earnings call, held on Wednesday. The biosimilar reached 20% market share, said the company, due in large part to its competitive contracting. The average selling price (ASP) for Udenyca declined by approximately 3%, which tracks the approximate 2% decline in ASP for the brand-name Neulasta.

The company noted that Udenyca has gained penetration into both the Neulasta prefilled syringe market segment and the on-body injector market segment.

Celltrion to Launch 1 New Product Per Year

In its own third-quarter earnings release, Celltrion revealed that its sales were up 23.0% quarter over quarter, and up 25.1% year over year. Sales growth was largely led by biosimilars scheduled for launch in the US and EU markets; the company this morning announced the launch its rituximab biosimilar, Truxima, in the United States, and its subcutaneous infliximab biosimilar, Remsima, is expected to launch soon in the European Union.

The company also said it plans to launch 1 new product every year through 2023; the Republic of Korea—based drug maker currently has a proposed bevacizumab biosimilar (CT-P16) and a proposed adalimumab biosimilar (CT-P17) in phase 3 clinical trials, and a proposed omalizumab biosimilar (CT-P39) in a phase 1 clinical trial. And additional 15 biosimilars are in cell-line development, process development, or review, and that group includes 6 immunology, 4 oncology, and 5 other proposed products.

Celltrion plans to keep pace with its goal by continuing to pursue accelerated research and development; according to the company, Celltrion’s products have obtained regulatory approval with shorter clinical trials—in fewer patients—compared with other drug makers.

Bio-Thera Gaines Chinese Approval for Adalimumab Biosimilar, Qleti

Bio-Thera announced Thursday that China’s regulatory body, the National Medical Products Administration, has approved the company’s adalimumab biosimilar. Bio-Thera will market the drug under the brand name Qleti. The company now will seek approval of the biosimilar in additional markets around the world.

Bio-Thera announced in July that the biosimilar, BAT1406, had met its primary end point of equivalent efficacy to reference adalimumab, Humira, in a phase 3 trial conducted in patients with active ankylosing spondylitis (AS).

The application submitted to the regulatory authorities includes a comprehensive data package that consists of analytical, preclinical, and clinical data. The clinical studies included a trial that investigated pharmacokinetic and pharmacodynamic data, as well as the phase 3 study in AS.

The drug maker is also developing biosimilar candidates of bevacizumab, tocilizumab, ustekinumab, and golimumab. Qleti is the company’s first biosimilar to be approved.

Alvotech Strikes a 7-Biosimilar Partnership With Stada

Finally, on Wednesday, Iceland-based Alvotech announced that it has entered into an exclusive partnership with Germany-based Stada to commercialize 7 biosimilars—including autoimmune, oncology, ophthalmology, and inflammatory disease therapies—in Europe.

Under the partnership, Alvotech will handle development, regulatory activities, and supply for the products in the European Union, while Stada will commercialize them in key markets.

Taken together, the biosimilars’ reference products are responsible for approximately $50 billion each year, said the companies.