In 3Q17, Pfizer (PFE) reported revenue of ~$141 million for its biosimilar portfolio, marking YoY (year-over-year) growth of ~70%. Its biosimilar revenue saw operational growth of 67% YoY in 3Q17. Pfizer reported biosimilar revenue of $367 million in the first nine months of 2017, YoY growth of ~61%.
On September 10, 2017, Pfizer reported positive results for its Phase 3 REFLECTIONS B327-02 trial, which demonstrated the equivalence of an investigational biosimilar version of Roche’s (RHHBY) Herceptin, PF-05280014, as first-line therapy in combination with paclitaxel, in terms of objective response rate in HER2[1.human epidermal growth factor receptor 2]-positive metastatic breast cancer patients. This data was presented at the ESMO (European Society for Medical Oncology) 2017 Congress. Pfizer has submitted regulatory approval applications to the FDA and European Medicines Agency for the biosimilar.
In November 2017, Roche sued Pfizer for infringement of 40 of its Herceptin patents by biosimilar PF-05280014. The company has also sought compensation for reduced sales in case Pfizer launches its biosimilar before the expiry of branded Herceptin patents.
On December 1, 2017, the FDA approved Mylan (MYL) and Biocon’s biosimilar, Ogivri, for all Herceptin indications, including gastric and gastroesophageal junction adenocarcinoma and HER2-overexpressing breast cancer. On November 17, 2017, the European Commission granted marketing authorization for Samsung Bioepis’s Ontruzant, a Herceptin biosimilar. Samsung Bioepis is a Samsung BioLogics-Biogen (BIIB) joint venture. In the next article, we’ll focus on Pfizer’s Inflectra and emerging market portfolio.