Chandavarkar said the company was also making good progress in generating additional clinical data to support the manufacturing site change of insulin Glargine from Bengaluru to Malaysia. Biocon
is also not anticipating any delay on the approval and launch time of Glargine in the US market, likely by early 2020, as all required activities agreed upon with the Food and Drug Administration (FDA) is in line according to the company.
Insulin Glargine is the first biosimilar
to be approved and launched in Japan.
It has also received regulatory approvals in the developed markets of EU and Australia.
Meanwhile, Biocon's US partner Equillium is working on clinical data for a rare disease (acute graft-versus-host disease (aGVHD) ). This assumes significance as the Biocon-Mylan's cancer drug Pegfilgrastim faces increased competition in US.
According to an IIFL report, Coherus BioSciences, a California-based biotechnology firm, has received US FDA
approval for its drug Udenyca (Pegfilgrastim). This is a copy of Amgen's drug Neulasta and is a competition to Fulphila (Biocon-Mylan's Pegfilgrastim biosimilar). Additionally, Udenyca has also received approval in Europe, becoming the first Pegfilgrastim biosimilar
approved by both the FDA
and the European Commission.
Mylan, which had launched Fulphila in the US in June, is still awaiting European approval for the biosimilar.
Fulphila was the first biosimilar to Neulasta to be approved by the FDA.
Biocon’s revenue from the biologics business, comprising novel biologics and biosimilars, had more than doubled to Rs 3.67 billion in the second quarter of the current financial year.
For the company, the next wave of biosimilar opportunities will open up towards the middle of the next decade in partnership with Sandoz, which is a division of Novartis. The development work on the Sandoz partnered biosimilar programmes has started and they are at pre-clinical stage. "Our R&D spends for these programmes will ramp up when these molecules enter the phase of clinical trials," said Chandavarkar.