SAINT-PETERSBURG, Russia--(BUSINESS WIRE)--Due to claims by Swiss drug-maker F. Hoffmann-La Roche, Ltd. in an attempt to cease the distribution of the Russian-made anti-tumor biosimilar products, as well as seeking to revoke BIOCAD’s product market authorization in Sri Lanka, cancer patients in this South-East country haven’t received the essential anti-cancer drugs trastuzumab and bevacizumab. After a series of hearings, in June 2016 the Court of Appeals of Sri Lanka finally dismissed the claims from the Swiss originator and terminated interim in relief.
In late March this year F. Hoffmann-La Roche Ltd. filed a lawsuit against a local distributor of BIOCAD in Sri Lanka, asking to ban the distribution of trastuzumab and bevacizumab manufactured in the Russian Federation by a leading Russian biotechnology company, JCS BIOCAD. The Plaintiff claimed that substantial violations of the drug manufacturing process had been committed by the agency during the approval. In particular, products by BIOCAD lacked proper clinical trials, and therefore no market authorization could have been issued for two BIOCAD’s products in Sri Lanka.
During a series of hearings in March 2016, BIOCAD provided assistance to the local partner, offering proof that the Plaintiffs’ claims were totally unfounded. The Court decided with the local distributor of BIOCAD’s products and dismissed F. Hoffmann-La Roche’s lawsuit, lifting its “stay order” on distribution and sales of two biosimilar drug products manufactured by BIOCAD in Sri Lanka.
Trastuzumab and bevacizumab produced by JSC BIOCAD. In multi-national clinical trials they were compared to the originator products before their use was approved. Hoffmann-La Roche’s lawsuit effected the provision of affordable cancer treatment in Sri Lanka and made patients wait for life-saving medication for several months.
The court case demonstrates that Russian biotechnology companies are expanding their business activities rapidly in foreign markets by offering high-quality products at lower prices. As court stated, it could be seen from the pleadings that since the granting of this interim relief it has become impossible to administer this drug (INN Trastuzumab) on patients suffering from cancer in Sri Lankan hospitals. In this particular case, JSC BIOCAD, although technically was not the respondent in the lawsuit by F. Hoffmann-La Roche Ltd. in Sri Lanka, has intentions of filing a lawsuit to oblige F. Hoffmann-La Roche Ltd to compensate the damage caused to JSC BIOCAD as well as provide evaluation and compensation of damage caused to the health of Sri Lankan patients resulting from non-competitive behaviour on the part of the Swiss drug manufacturer.
