Russia approves first ever biosimilar of Serono’s MS drug Rebif
The Russian firm has GMP-compliant manufacturing facilities in Moscow, and a second facility close to its headquarters in Saint Petersburg, which is where the active pharmaceutical ingredients for interferon beta-1a are produced.
Roman Ivanov, VP of R&D at Biocad, told us CHO cells are used to produce the interferon beta-1a APIs using 1,000L single-use HyClone bioreactors at the St Petersburg site.
The 2,000m2 site has a monoclonal antibody capacity of up to 160kg a year, and scale up to meet the market demand for interferon-based products would not be an issue.
“Despite the fact that interferon beta-1a is one of the biggest selling products in Russia, the annual demand for this product can be managed using just several fermentation bioreactors,” Ivanov explained.
“It’s nothing compared to the volume of monoclonal antibodies the facility produces,” he continued, adding that finishing process of interferon beta-1a takes place at the Moscow facility.
Biocad has a number of biosimilar products on the Russian market, including a version of Roche’s Herceptin (trastuzumab) approved last January.
EMA guidelines
The Rebif biosimilar was developed in accordance with EMA guidelines.
“Marketing approval [of Biocad’s interferon beta-1a] was based on this one year of data, and we're now continuing administration of the biosimilar to generate additional long-term data,” said Ivanov.
Non-clinical development of BIOCAD’s next-in-class humanised anti-CD20 antibody, is also projected to enter clinical development for MS later this year.
“The company is even developing three generics of second generation disease modifying drugs for MS: fingolimod, dimethyl fumarate, teriflunomide,” Ivanov added.
