- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Biocon Says FDA Issues Form 483 to Insulin Plant in Malaysia
This is the third Form 483 Biocon has received for the insulin plant in 3 years.
Biocon said this week it received a Form 483 letter from the FDA related to an inspection at its insulin manufacturing plant in Malaysia, where the company will produce its insulin glargine product, referencing Sanofi’s Lantus.
In a filing with India’s stock exchange, Biocon said the FDA conducted a pre-approval inspection of the facility between February 10 and February 21. The notice includes “3 observations, which we believe are procedural in nature,” the company wrote.
The follow-on product is already authorized in the European and Australian markets, where the product is regulated as a biosimilar and is sold under the brand name Semglee.
In the United States, the product has a target action date set for June; Biocon said in its announcement it does not “believe the outcome of this inspection does not in any way impact the commercialization plans."
However, Biocon’s Malaysian plant has been the subject of numerous regulatory challenges in 2018 and 2019. The company received a Form 483 from the FDA, inclusive of 6 observations, in 2018, and another inspection of the site in June and July 2019 yielded another Form 483 with 12 observations.
In August 2019, it received a certificate of good manufacturing practice from the European Medicines Agency’s Irish inspection authority.
With the latest notice, Biocon said it is confident of addressing the observations "expeditiously" and said it is committed to "global standards of Quality and Compliance."
Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share
October 11th 2024Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.
"Not So Different": How the BPCIA Transition Will Affect Biosimilar Uptake
April 10th 2020This week on the podcast, we’re speaking with the executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), Cate Lockhart, PharmD, PhD, about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how the new approval pathway for biologics will affect the pace at which biosimilars come to market.
CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel
August 19th 2024CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.
Indian Providers Boast Interchangeability for Insulin Biosimilars Despite Debates in the US
August 5th 2024The introduction of biosimilar insulins, particularly insulin glargine, is crucial for improving insulin accessibility and adherence among patients with diabetes in India, according to a study evaluating expert opinions from Indian doctors.
