Biocon’s hopes of getting approvals for three major biosimiar products approved in US and Europe, now hinges on addressing the observations raised by US FDA and Europe drug regulator European Medicines Agency (EMA) on its Bengaluru facility.
Biocon’s hopes of getting approvals for three major biosimiar products in the US and Europe now hinge on addressing the observations raised against its Bengaluru facility by the USFDA and Europe drug regulator EMA.
The USFDA completed a pre-approval inspection (PAI) of Biocon's sterile drug manufacturing facility in Bengaluru earlier this month and issued Form 483 with seven observations.
The EMA (European Medicine Authority) for the same facility inspected in March 2018 issued six major observations.
Biocon said it plans to respond to both the agencies within 15 working days with its corrective and preventive action plan (CAPA), as per the stipulated timelines. Biocon said the observations by USFDA are procedural and aimed at continuous improvement, while EMA’s observations were not critical.
The Bengaluru facility is critical for Biocon’s regulated market play for biosimilars.
It has already received an approval for biosimilar Trastuzumab in the US but filings for biosimilar Pegfilgrastim in US and EU, and Trastuzumab in EU are pending approval.
Biocon target action day (TAD) for Pegfilgrastim in the US is on June 4, 2018, while the EU opinions on Pegfilgrastim and Trastuzumab are likely to come in by 2018-end.
Target action day refers to the day on which USFDA will announce its decision.
In addition to these approvals, Biocon has busy year ahead in terms of biosimilar launches. The company is in the process of rolling out insulin glargine with its partner Mylan in Australia and Europe in the second half of 2018.
The company said it will be launching insulin glargine later this year with the help of local partner in South Korea. Trastuzumab, which is already approved in Turkey, is expected to be launched in the United States towards the end of FY19.
Biosimilars are identical copies of original biologic drugs that have active properties similar to the reference biological product requiring large clinical trials on patients to establish safety and efficacy before approval by regulatory agencies, unlike small generic molecules that can be launched by doing bioequivalence studies.
Biocon’s CEO Arun Chandavarkar, in post earnings interview to Moneycontrol, expressed confidence about Biocon meeting the guidance of USD 200 million, which it had set for the biologics business.
“The prospects for FY19 look exciting with growth in biologics segment led by developed and emerging markets,” Chandavarkar said.
“Higher sales of products in FY19 should help boost biologics segment margins which will be partly offset by R&D expenses on biosimilars and novel biologics.”
Analysts tracking the company said they are still bullish about Biocon's bet on biosmilars.
"The fresh pre-approval inspection (PAI) observations provided by the USFDA and EMA may result in near-term volatility, but the long-term story seems intact with monetization of key products in the coming quarters," said Morgan Stanley in its report."Biocon is the most leveraged Indian play on global biosimilars and
2018 could be a year of inflection. We have not seen the latest observations yet but management commentary appears to suggest that they are unlikely to be meaningfully disruptive," said Citi Research."We would not rule out approval delays but do not see meaningful impact on commercialization timelines as there is no meaningful contribution expected from biosimilars in developed markets before CY19," the Citi Research added.