Following an inspection by Ireland’s Health Products Regulatory Authority (HPRA) in May 2019, the facility located in the Biotech Park in Johor, Malaysia, received a certificate of good manufacturing practice (GMP) compliance.
Biocon opened the facility in 2017, after investing $275m (€249.15m) in its construction. A previous European Union (EU) GMP certificate was awarded at the site following an inspection from the HPRA in September 2017.
The facility manufactures insulin drug products and delivery devices. According to the company, it is the largest integrated insulin manufacturing facility in Asia, with approximately 600 employees.
Since 2017, the company is also engaged in a contract with the Malaysian government to supply recombinant insulin made at the facility to healthcare clinics and hospitals across the country.
Mylan’s biosimilar to Sanofi’s Lantus, Semglee (insulin glargine), manufactured by Biocon at the Johor facility, received approval from the European Medicines Agency (EMA) in March 2018, and is marketed in Europe since November 2018.
The approval for Semglee, however, suffered a setback when the EMA outlined 35 deficiencies during an inspection at the company’s fill/finish facility in Bangalore, India.
US regulatory blockages
The Asian company has also experienced regulatory blockages regarding its Malaysian facility by the US Food and Drug Administration (FDA).
A site inspection conducted by the FDA in February 2018 had led to the company receiving a Form 483 with six observations, raising concerns about insufficient cleaning and maintenance of the equipment, risks of microbiological contamination and inadequate quality assurance procedures.
A spokesperson for the company told us that the above regulatory issues, both with the FDA and with the EMA, have been resolved at the time of writing.
Earlier this year, however, the FDA inspected the Malaysian site again and issued Biocon another Form 483 with 12 observations.
"Subsequently, we have submitted our response to the US FDA and have started addressing the observations," the spokesperson said, regarding the latest blockages, adding: "We are working closely with the regulator and remain confident of being able to address all of these in a timely manner."