Roche to up Russian Gazyva supply through local fill/finish deal

Local manufacturer Pharmstandard will make the finished dosage form of Roche’s monoclonal antibody Gazyva (obinutuzumab) at its site in Ufa.

Pharmstandard has been working with the Swiss pharma firm since 2010, helping bring Roche/Genentech products such as Pulmozyme (dornase alfa) and Tamiflu (oseltamivir) to the Russian market, and will now produce the drug product for Gazyva, a treatment for chronic lymphocytic leukemia (CLL).

“Our Roche affiliate and the Russian manufacturer Pharmstandard have signed a Memorandum of Understanding for the ‘fill-finish’ production of Roche's drug product Gazyva in Pharmstandard's manufacturing operations in Russia,” a Roche spokesperson told Biopharma-Reporter.

“Local production of Gazyva would expand treatment options for Russian patients with chronic lymphocytic leukemia and follicular lymphoma.”

The 42,000m2 facility is located in Ufa, Republic of Bashkortostan (a federal subject of Russia), and boasts capabilities for injectables, vials, cartridges and prefilled syringes, as well as solid oral dosage form manufacture.

Made in Russia

The partnership allows Roche to access the Russian market which, under its Pharma 2020 policy, encourages a level of protection intended to increase local drug manufacture and reduce reliance on imports.

The idea is Russia will be able to produce 50% of all the drugs it uses - and 85% of the medicines it deems essential - by 2020, though whether this target will be reached is unclear.

The policy has driven most multinationals to sign contracts with domestic drugmakers and invest in local joint ventures. Pfizer broke ground on a facility with NovaMedica in Kaluga in May, GSK formed a JV with Binnopharm in 2011, while AstraZeneca , Novartis and Novo Nordisk have all invested in Russian production facilities.

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