Biocon receives EIR from USFDA for good manufacturing practice inspection

Biocon on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good manufacturing practice (GMP) inspection of its small molecules manufacturing facility in Bengaluru.
"The EIR has been closed with a voluntary action indicated (VAI) classification for the observations, the company spokesperson said in a filing to BSE.

"Biocon has received the EIR from the US Food and Drug Administration (FDA) for the post-approval and GMP inspection of its small molecules active pharmaceutical ingredient (API) manufacturing facility at 20th KM, Biocon Campus, Bengaluru, conducted between Feb 20 and Feb 26, 2020," as per the filing.
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#Biocon's USFDA Inspection of its small molecule API facility held in Feb 2020, stands closed with EIR classifying two observations as VAI. Company is addressing these procedural observations. http://bit.ly/PR200320
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At the conclusion of the inspection last month, the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the company, the filing said.
"We remain committed to global standards of quality and compliance," company spokesperson added.
The shares of Biocon were trading at Rs 257.00 apiece on the BSE, up 1.76 from the previous close.

Biocon moves up to sixth spot in Global Biotech Employers ranking

Bengaluru-headquartered biopharmaceuticals company Biocon Ltd has moved up to sixth spot in the Top 10 Global Biotech Employers ranking for 2019.
It continues to be the only company from Asia to feature on the prestigious US-based 'Science' magazine's annual 'Science Careers Top 20 Employers' list, since its debut in 2012.
Ranked at number six among global pharma and biotech companies in 2019, Biocon has moved up from number seven in 2018 and number nine in 2017.
Biocon said in a statement it has been consistently recognised for three key attributes: "Innovative leader in the industry, 'is socially responsible' and leadership makes changes needed."
The ranking is a result of the 2019 Science Careers Top Employers global survey conducted by the US-based Science magazine to determine which companies in the biotech and pharmaceutical industry have the best reputations as employers globally.
Kiran Mazumdar Shaw, CMD, Biocon said: "We have consciously created a culture that encourages ideation, experimentation and collaboration to address unmet patient needs."

Biocon was ahead of leading global pharma companies like Novozymes, Roche, Eli Lilly, Abbott, Novartis, Pfizer etc. in the 2019 rankings.
The Top 5 global players in this year's list are Alnylam, Regeneron, Incyte, Merck KGaA and Spark therapeutics.
Respondents to the web-based survey were asked to rate companies based on 23 characteristics, including 'innovative leader in the industry,' 'treating employees with respect,' 'is socially responsible,' 'work culture values aligned' and 'leadership makes changes needed,' it was stated.

The obvious opportunity is biosimilars, says Biocon's Kiran Mazumdar-Shaw

Biocon, which has aggressively invested in the biologics business, grew at an impressive 47 per cent in the March quarter, with the segment accounting for over a fifth of the company's revenue. A year ago biologics contributed 17.5 per cent to the biopharmaceutical firm’s revenue. The biopharmaceutical company's profit before interest and tax grew 22 per cent to Rs 1.93 billion, aided by biologics, which turned in a profit of Rs 194 million.
For Biocon, it is really biosimilars that will push the needle going ahead. Shorn of jargon, biosimilars are biological products that are highly similar to and have no clinically meaningful differences with an existing FDA-approved reference product while biologics are drugs made extracted or synthesised from biological sources. “The obvious opportunity is biosimilars, which are simpler but more expensive,” says Kiran Mazumdar-Shaw, founder of Biocon.

A month ago, Biocon announced that its biosimilar insulin glargine trademarked as Semglee received marketing approval from the European Commission following approvals by the Committee of Medicinal Products for Human Use. Semglee, which is a pre-filled disposable pen for diabetes patients, is the first product to come out of a joint portfolio from Biocon and Mylan. At the time, Arun Chandavarkar, CEO and joint managing director, Biocon, had said the approval furthered the mission to provide a high quality, affordable insulin analog for diabetes patients globally. The difference between biosimilars and a small molecule generic is largely in the cost of development. A small molecule generic can cost between $10 million and $30 million while a biosimilar molecule can cost anywhere from $150 million to $300 million.
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An analyst who tracks the sector says that on average clinical trials and regulatory testing are far more stringent whereas human trials are not required for small molecule generics. Also, in the next three years, biologics worth $100 billion will go off-patent in the US, of which half the opportunity can be exploited by biosimilars, says Deepak Malik, healthcare analyst with Edelweiss Securities.
While the Mylan approval may not have created too many waves, for Mazumdar-Shaw, it was vindication of what she calls “a 10-year old journey fraught with a lot of scepticism and investor concern”. She admits that in the past Biocon has been called “a confused company,” and there may have been some truth to it. Not that the journey with biosimilars has been accepted as easily for when she started there was little regulatory visibility on what US and EU authorities expected. She was, of course, convinced that with spiralling healthcare costs the world at large would have to embrace the technology that allowed for all drug makers to create affordable alternatives and thus decided that it was a bet worth taking. Shaw says that she has invested at least $1 billion on biosimilars over the past decade.
“Biosimilars represent the fourth inflection point in the company's journey,” she says. The first was shifting from enzymes-based drugs to biopharma; the second was the launch of insulin drugs in the Indian market; and the third was when the company went public.
She is aware that her big challenge with the new class of drugs is going to be speedy execution, because commercial success in getting to market is one thing — getting the right market share is another altogether. “It is key for Biocon to act swiftly because there are lots of push-backs and tactics adopted by innovators to stop you in your tracks. We are watching that," Shaw says. That is not the only competition she has to take on. Chinese and South Korean majors as well as deep-pocketed Western manufacturers like Pfizer and Amgen are already front-runners in that race. “The only Indian maker on the front foot is Biocon and it has smartly gone that way with a strong alliance,” Malik adds, referring to the tie-up with Mylan.
Biocon has nine different molecules that it is working on just with Mylan, Shaw says.
Other analysts who declined to be named point to succession as a potential challenge for Biocon — who after Mazumdar-Shaw? Her answer is, “I am just the hands-off leader who plays the strategic visionary and happens to be the face of the firm while the rest of it is being run by professionals.” She clarifies that family-run businesses operate differently from founder-run businesses. Of course, she says that all her professional heads — CEOs, COOs and CFOs — are empowered to take calls they need to and at the end of the day “every single company was founded by someone, whether they are around or not and remembered or not”.