Biosimilar Business News Roundup: Russia Launches Omalizumab; Remsima Sales Soar; Xbrane Trial Results

Omalizumab Biosimilar Launches in Russia

Selexis and Generium shared that they have launched Genolar, a biosimilar for omalizumab (Xolair) on the Russian market for the treatment of persistent atopic bronchial asthma and resistant chronic idiopathic urticaria for patients aged 6 years and up.

“Individuals coping with chronic diseases such as atopic asthma deserve access to novel, affordable medicines. The introduction of effective biosimilars like Genolar makes that possible, while also aligning with Selexis’ patient-centric mission,” said Roland Hecht, PhD, chief business officer at Selexis.

The drug is the first Selexis SUREtechnology Platform-generated biosimilar to reach that market under a commercialization partnership with Generium. The biosimilar is also cleared for use in patients with chronic spontaneous urticaria in patients aged 12 years and older with elevated immunoglobulin E (IgE) who are unresponsive to antihistamine treatment. Omalizumab is a recombinant humanized monoclonal antibody that bind to free human IgE.

Celltrion Sales for Remsima Hit Record High

According to Yonhap News Agency, sales of Celltrion Healthcare’s infliximab biosimilar Remsima reached a new record in 2021 in the United States, jumping up 13% in year-over-year growth to $385 million.

Remsima references Remicade and has been on the US market since November 2016, when it launched under the name Inflectra as part of a commercialization partnership between Celltrion and Pfizer. Remsima is used to treat patients with rheumatoid arthritis and several other rheumatologic conditions.

At the end of 2021, the market share for the biosimilar amounted to 22.3% in the United States, which is lower than Remicade’s 67.2% market share but it is still gaining traction. Over the last 5 years, sales of the reference product had been cut by nearly half, from $4.5 billion in 2017 to $2 billion in 2021, following the launch of Celltrion’s product.

The news of the record breaking growth comes around the same time as Hikma Pharmaceuticals announced the expansion in its licensing agreement with Celltrion over the subcutaneous version of Remsima for their Middle Eastern and North African (MENA) markets. The expansion builds on the companies’ existing partnership for 3 biosimilar products, including Truxima (rituximab), the original Remsima formulation, and Herzuma (trastuzumab).

“Subcutaneous administration has been shown to be effective, safe, well-tolerated and generally preferred by patients. This new formulation enables administration outside of the hospital setting, allowing more patients access to the treatment,” said Mazen Darwazah, the executive vice chairman of Hikma and president of MENA.

Hikma’s MENA markets include those in Algeria, Egypt, Iraq, Jordan, Morocco, Tunisia, the United Arab Emirates, and Saudi Arabia.

Xbrane Shares Trial Results for Lucentis Biosimilar

Xbrane Biopharma announced positive phase 3 trial results demonstrating equivalent efficacy for its ranibizumab biosimilar Xlucane in comparison with the reference product (Lucentis) over 12 months.

The company said that the results will help the company along its journey for regulatory approval for various markets. Ranibizumab is a blood vessel growth inhibitor used to treat neovascular age-related macular degeneration (wet AMD), macular edema, and diabetic retinopathy.

The company said that the Xplore study results revealed no clinically meaningful differences in safety, efficacy, pharmacokinetics, or immunogenicity between the 2 drugs. The Xplore study is a randomized, double-blinded, multi-center study comparing the safety and efficacy properties of Xlucane compared with the reference product in patients with wet AMD. The study pulls data from 583 patients from 140 clinics in 15 countries.

Previous data shared from the trial demonstrated equivalent efficacy in the change of best corrected visual acuity after 8 weeks of treatment compared to the reference product.