EC Approves First MS Biosimilar; Coherus Receives CRL for Neulasta Onpro Competitor

The European Commission (EC) approved Tyruko, the first natalizumab biosimilar and first biosimilar to treat multiple sclerosis (MS) approved in Europe, and Coherus Biosciences received a complete response letter (CRL) from the FDA regarding its biosimilar competitor for Neulasta Onpro.

EC Approval of Tyruko

The EC granted marketing authorization to Tyruko, a natalizumab biosimilar referencing Tysabri. The product was developed by Polpharma Biologics, a Poland-based pureplay biosimilar manufacturer, and will be marketed by Sandoz as part of a global commercialization agreement.

Tyruko was approved as a single disease-modifying therapy in adults with highly active relapsing-remitting MS (RRMS), the same indication as approved by the EC for the reference medicine. The European approval comes 2 months after the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion on Tyruko and one month after the FDA approved the drug for the US market.

“This biosimilar is extremely big news,” said Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, in an interview with The Center for Biosimilars^® regarding the US approval. "I know there's so much focus on the adalimumab biosimilars right now but introducing a brand new therapeutic area, with neurology and a biosimilar, is very, very exciting."

The EC based its approval on the analytical, preclinical, and clinical data collected from a phase 1 pharmacokinetic and pharmacodynamic study and the phase 3 ANTELOPE study, which confirmed the comparable safety, efficacy, and immunogenicity profiles of Tyruko and the originator in patients with RRMS.

“We are delighted that the European approval of Tyruko comes hot on the heels of approval in the US, meaning that millions of people living with multiple sclerosis around the world may soon have the option of a more affordable treatment for their disease….,” commented Michael Soldan, CEO, Polpharma Biologics Group. "We’re building on this extensive scientific and manufacturing expertise to further advance our pipeline of other high potential biosimilar targets."

Natalizumab biosimilars can help ease the burden of high costs related to MS treatment, which is estimated to cost health systems as much as €37,000 to €57,000 ($38,881-$59,899) per patient per year.

CRL for Neulasta Onpro Biosimilar

Coherus Biosciences received a CRL for its biosimilar of Neulasta Onpro, a biobetter of the original Neulasta (pegfilgrastim) formulation that allows for an on-body injector device. Pegfilgrastim products are used to lower a patient’s risk of developing febrile neutropenia, a potentially life-threatening condition that can result after receiving chemotherapy.

The CRL will delay the anticipated US approval of the on-body product. However, it does not impact the sales or regulatory status of Udenyca (pegfilgrastim-cbqv), Coherus’ original pegfilgrastim biosimilar. Udenyca was approved in November 2018 and launched on the US market in January 2019. It is 1 of 6 pegfilgrastim biosimilars approved for the US market.

The letter comes after the FDA approved the autoinjector version of Udenyca in March 2023. The autoinjector device allows for patients to be administered pegfilgrastim the day after receiving chemotherapy, decreasing the risk of patients developing febrile neutropenia. The Udenyca autoinjector is triggered by push-on-skin activation, allowing for reliable and immediate delivery of a full pegfilgrastim dose.

Coherus assured that the FDA did not raise any issues with the on-body product’s safety or efficacy, saying that the CRL was issued because of an ongoing review at a third-party manufacturing site.