Biocon, one of India’s leading biopharmaceutical companies, faced a setback on Wednesday, 18th October 2023, when the US Food and Drug Administration (USFDA) issued a warning letter to its subsidiary in Malaysia, Biocon Sdn Bhd., for violating the current good manufacturing practice (cGMP) standards at its insulin manufacturing facility in Johor.
The USFDA inspected the facility in July 2023 and found several deficiencies in the quality system, equipment maintenance, environmental monitoring, and batch release procedures. The agency classified the inspection as ‘OAI’ (Official Action Indicated), which means that it may recommend regulatory or administrative actions against the company. The OAI status may also cause delay or withholding of pending product approvals or supplements from the facility.
Biocon said that it had submitted a comprehensive corrective and preventive action (CAPA) plan to the USFDA in response to the observations and believed that it was on track to complete all actions as committed. The company also said that it would continue to engage with the agency to understand any outstanding concerns and work closely to address them expeditiously. Biocon claimed that the warning letter would not have a material impact on the manufacturing and distribution of its commercial products for the US market.
However, the market did not seem to share Biocon’s optimism, as its shares dropped by 4% on Wednesday, hitting a 52-week low of Rs 243.50 on the BSE. The stock has been underperforming for the past year, losing about 10% of its value. Analysts said that the warning letter was a serious setback for Biocon’s biosimilar ambitions, as it could delay its entry into the lucrative US insulin market.
Biocon has been developing biosimilars of insulin products such as Lantus, NovoLog, and Humalog in partnership with Mylan, a US-based generic drug maker. Biosimilars are cheaper versions of biological drugs that have similar safety and efficacy as the original products. The global insulin market is estimated to be worth $27 billion by 2025, with the US accounting for about 40% of it.
Biocon had received tentative approval from the USFDA for its biosimilar version of Lantus, called Semglee, in June 2020. However, the final approval was contingent on resolving the issues at the Malaysian facility, which is the sole supplier of Semglee for the US market. The warning letter could further delay the launch of Semglee in the US, giving an edge to its competitors such as Eli Lilly and Sanofi.
Biocon’s troubles are not limited to Malaysia. The company also received form 483s from the USFDA for three of its sites in Bengaluru in September 2023, with 11 observations each for violating cGMP standards. Form 483s are issued when inspectors find conditions that may constitute violations of the Federal Food, Drug, and Cosmetic Act and related regulations. Biocon said that it was confident in addressing these observations and did not expect any impact on its existing or future product supplies from these facilities.
Biocon’s woes come at a time when it is facing increasing competition from other Indian players in the biosimilar space. Companies such as Dr Reddy’s Laboratories, Lupin, Zydus Cadila, and Intas Pharmaceuticals have also been developing and launching biosimilars of various biologic drugs in domestic and international markets. Biocon’s edge lies in its strong pipeline of biosimilars, which includes 11 products across oncology, immunology, diabetes, and ophthalmology segments. However, to realize its full potential, Biocon needs to overcome the regulatory hurdles and ensure quality compliance at its manufacturing sites.
This post USFDA’s Warning Shakes Biocon: Shares Drop by 4% in Malaysia was originally published at Finance Crave
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