The European Medicines Agency Committee for Medical Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri, a biosimilar to Roches Herceptin (trastuzumab), Biocon Limited and partner Mylan N V announced Friday.
The results, said Biocon, demonstrated no clinically meaningful differences in quality, potency and safety and hence, establishing biosimilarity to the reference product, Herceptin.
"The positive CHMP opinion is based on data submitted as part of the Marketing Authorisation Application which included similarity assessment in analytical testing, preclinical and clinical studies," Biocon said in a release.
In addition, the Phase III clinical study (Heritage) demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity when compared to Herceptin in metastatic breast cancer patients, further reinforcing the highly similar nature of Ogivri, the biotech firm said.
The CHMP positive opinion will now be considered by the European Commission, said Biocon, adding that the decision on approval is expected by the end of 2018.
Ogivri is indicated for treatment of patients with HER2 positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC), the company said.
Dr Arun Chandavarkar, CEO and joint managing director, Biocon, said, "This is the third molecule from our collaboration portfolio to receive positive opinion from the European CHMP.
We shall continue to execute on our biosimilars strategy of expanding affordable access to high quality products targeting critical illnesses like cancer."
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