Mylan and Biocon have announced the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Ogivri – a biosimilar to Roche’s Herceptin (trastuzumab).
Ogivri, Mylan and Biocon’s third biosimilar to receive positive opinion from the CHMP, is indicated for the treatment of patients with HER2 positive early breast cancer, metastatic breast cancer or metastatic gastric cancer.
The monoclonal antibody was co-developed by Mylan and Biocon, and manufactured at the latter’s Bangalore site in India. Mylan holds the rights to commercialise Ogivri in the US, Canada, Japan, Australia, New Zealand, and Europe.
The European Commission (EC) will review the CHMP’s assessment, with a final decision expected before the end of 2018.
Roche confident in portfolio
Blockbuster Herceptin – which, according to IQVIA, had brand sales of approximately $1.9bn (€2.15bn) in Europe for the 12 months ending July 31, 2018 – first received EC approval in 2000.
Roche is facing growing competition from Herceptin biosimilar developers in Europe, including from Samsung Bioepis’ Onstruzant, which became the first Herceptin biosimilar to receive European approval in November last year, and from Pfizer’s Trazimera, approved mid-2018.
Roche spokesperson, Anja von Treskow, told us the company trusts its portfolio will offset increasing biosimilar uptake.
“We see the very strong uptake of our recently launched medicines, and we are therefore confident that these will compensate the biosimilar impact and drive growth,” said von Treskow.
“As announced during our nine months results, 90% of our growth comes from new products,” she added.
A smooth run
Mylan and Biocon’s Ogivri became the first Herceptin biosimilar to receive US Food and Drug Administration (FDA) approval last year – albeit several months later than expected.
The good manufacturing practice (GMP) concerns responsible for the FDA’s decision to delay its action date, which consequently delayed approval, do not appear to have impacted Ogivri’s path towards commercialisation in Europe.
“We received EU GMP certification for our Bangalore facilities in July 2017 for the drug substance and in July 2018 for the drug product,” Biocon’s CEO Arun Chandavarkar told us.
“The dossier review leading up to the positive CHMP opinion has progressed as per schedule since then. We now await EC approval by the end of 2018, which is again as per a defined schedule set out by the European agency,” he added.