Tuesday Nov 26, 2024
Tuesday Nov 26, 2024
Thursday, 7 July 2016 00:00 - - {{hitsCtrl.values.hits}}
The Court of Appeals has dismissed a lawsuit by Swiss drug-maker F. Hoffmann-La Roche Ltd. against BOIOCAD, the Russian manufacturer of the anti-cancer drugs Trastuzumab and Bevacizumab.
Due to claims made by F. Hoffmann-La Roche Ltd., in an attempt to cease the distribution of the Russian-made anti-tumour biosimilar products and seek a revocation of BIOCAD’s product market authorisation in Sri Lanka, cancer patients in Sri Lanka have not received the essential anti-cancer drugs Trastuzumab and Bevacizumab, according to a statement released by BIOCAD.
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 filed a lawsuit against a local distributor of BIOCAD in Sri Lanka calling for a ban on the distribution of Trastuzumab and Bevacizumab manufactured in Russia by BIOCAD.
F. Hoffmann-La Roche 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 authorisation could have been issued for two of BIOCAD’s products in Sri Lanka.
During a series of hearings in March 2016, BIOCAD provided assistance to the local partner, offering proof that F. Hoffmann-La Roche’s 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 the distribution and sale of two biosimilar drug products manufactured by BIOCAD in Sri Lanka.
In multi-national clinical trials Trastuzumab and Bevacizumab 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 proceedings that since the granting of this interim relief it has become impossible to administer this drug (INN Trastuzumab) to patients suffering from cancer in Sri Lankan hospitals. In this particular case, BIOCAD, although technically not the respondent in the lawsuit filed by F. Hoffmann-La Roche, intends to file a countersuit demanding that F. Hoffmann-La Roche pay compensation for damages caused to BIOCAD. The lawsuit will also call for the evaluation and compensation of damages caused to the health of Sri Lankan patients resulting from the non-competitive behaviour on the part of the Swiss drug manufacturer.
