FDA Inspection Update: Lupin's Mandideep Facility Clears US FDA Audit, Amgen's New Biosimilar Wins Approval
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FDA Inspection Update: Lupin’s Mandideep Facility Clears US FDA Audit, Amgen’s New Biosimilar Wins Approval

FDA Inspection Update: The FDA’s rigorous inspection regime has recently brought several key developments to the forefront. Lupin Limited’s Mandideep Unit-2 facility has successfully navigated an FDA inspection, securing the company’s ability to continue its supply of generic medications to the U.S. market. This approval is particularly crucial for Lupin, as the U.S. represents its largest consumer base.

In another significant development, Amgen’s Wezlana, a biosimilar to Johnson & Johnson’s Stelara, has received FDA approval. Notably, it has been granted interchangeability status, which is a first for ustekinumab biosimilars. This designation allows for the substitution of Wezlana at the pharmacy level across most states, potentially broadening patient access to this therapeutic option.

FDA Inspection Update: Lupin's Mandideep Facility Clears US FDA Audit, Amgen's New Biosimilar Wins Approval

FDA Inspection Update: Lupin’s Mandideep Facility Clears US FDA Audit, Amgen’s New Biosimilar Wins Approval

Lupin’s Mandideep Facility Passes US FDA Inspection

FDA Inspection Update: Lupin Limited has announced that its Mandideep Unit-2 manufacturing facility located in Madhya Pradesh, India, has successfully passed the US FDA inspection. This clearance allows the company to continue supplying its generic oral solids and injectables from this facility to the US market, which is Lupin’s largest.

Amgen Scores FDA Approval for Stelara Biosimilar

FDA Inspection Update: Amgen has received FDA approval for its biosimilar version of Johnson & Johnson’s Stelara, known as Wezlana (ustekinumab-auub). This biosimilar has also been granted interchangeability status, allowing for substitution at the pharmacy level in most states.

FDA Approves First Ustekinumab Biosimilar with Interchangeability Designation

FDA Inspection Update: The FDA has approved the first ustekinumab (Stelara) biosimilar, Wezlana (ustekinumab-auub) from Amgen, which has also been granted interchangeability status. This biosimilar is approved for several conditions, including moderate to severe plaque psoriasis and psoriatic arthritis. Its launch is expected to be delayed until 2025 due to a patent lawsuit settlement.

Furthermore, industry experts have shared valuable advice on managing FDA inspections, emphasizing the importance of communication and cautioning against certain responses that could negatively impact the inspection outcome.

Lastly, the FDA’s approval of the first interchangeable ustekinumab biosimilar marks a significant milestone in the biosimilar market. This approval is expected to foster a competitive environment, enhancing the availability of safe and effective medications at potentially lower costs.

These developments underscore the FDA’s commitment to ensuring the safety and efficacy of pharmaceutical products while also fostering innovation and accessibility in the healthcare market.