The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) held its monthly meeting on March 23-26, 2020. During the meeting, the CHMP reported important updates on the status of the approval process for biosimilars relating to etanercept and rituximab.
- Nepexto® (Etanercept)
At the meeting, the CHMP adopted a positive opinion that recommended the grant of a marketing authorization for Mylan IRE Healthcare Ltd.’s Nepexto® product. The CHMP approved Nepexto®, a biosimilar of Enbrel®, for all of the same indications as Enbrel® including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis, and pediatric plaque psoriasis. Enbrel® was previously approved for use in the European Union (EU) on February 3, 2000. The CHMP concluded that Nepexto® “is highly similar to the reference product Enbrel (etanercept)” and “[d]ata show that Nepexto has comparable quality, safety and efficacy to Enbrel.” The CHMP adopted this opinion after completing an assessment of the biosimilarity between Nepexto® and Enbrel® based on preclinical and clinical studies demonstrating bioequivalence to the reference product.
The European Commission will now consider the CHMP’s positive opinion and determine whether to approve Nepexto®. If approved, the European Commission will grant authorization allowing Nepexto® to be marketed by the member countries of the EU. The EC’s decision on approval is expected in May 2020.
At the meeting, the CHMP also reported that on March 16, 2020, Mabion S.A. (Mabion) withdrew its applications for initial marketing authorization for two rituximab biosimilars. Rituximab Mabion was intended for the treatment of certain blood cancers (non-Hodgkin’s lymphoma and chronic lymphocytic leukemia) and certain inflammatory diseases (severe rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis).
Initially, to support its applications, Mabion submitted laboratory studies to demonstrate that Rituximab Mabion’s structure, purity, and biological activity were highly similar to the reference product, MabThera. Mabion also presented a primary study of 629 rheumatoid arthritis patients that compared the effectiveness of Rituximab Mabion to MabThera.
Mabion withdrew its applications after the European Medicines Agency (EMA) evaluated the submitted information and prepared questions for the company. At the time of the withdrawal, the EMA held the provisional opinion that Rituximab Mabion could not be authorized for the requested indications. The CHMP reported that the EMA “was concerned that biosimilarity between Rituximab Mabion and the reference medicine MabThera had not been established” and “had concerns about the manufacturing process and the system for ensuring reliable quality of the medicine.”
Following the release of the meeting highlights, Mabion issued a report on March 30, 2020, explaining that the reason for the withdrawal was a change in its regulatory strategy. Mabion explained that its applications were initially based on “a two-step strategy (obtaining small-scale marketing authorization, followed by a subsequent submission of a variation application relating to a large-scale manufacturing process).” However, in view of its “goal to register a product based on a commercially attractive large-scale quality process”, Mabion decided to withdraw the application for the small-scale process. Mabion is preparing a new marketing authorization application for Rituximab.
 “Summary of opinion (initial authorisation),” Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/114945/2020 (March 26, 2020), available at https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-nepexto_en.pdf
 “Withdrawal of applications for the marketing authorisation of Rituximab Mabion”, European Medicines Agency, EMA/163447/2020 (March 27, 2020), available at https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_en.pdf
 “Information on the withdrawal of registration applications for MabionCD20 from the EMA,” Mabion S.A., (March 30, 2020), available at https://www.mabion.eu/media/filer_public/e9/a1/e9a17bd5-75fc-4696-a8df-a146299b0ee2/rb_19eng.pdf