Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second Complete Response Letter (CRL) for their follow-on insulin glargine product referencing Lantus.
Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second Complete Response Letter (CRL) for their follow-on insulin glargine product referencing Lantus.
According to Mayank Verma, the company’s secretary and compliance officer, in an August 31 letter to the National Stock Exchange of India, “The CRL has been issued pending completion of the Corrective And Preventive Actions…submitted to the US FDA in response to the observations made at the conclusion of the pre-approval inspection of our insulin manufacturing facility in Malaysia in June 2019.”
Verma added that the CRL did not note “outstanding scientific issues” with the application, and said that the CRL was not anticipated to have an impact on the company’s planned launch timeline.
This new regulatory challenge comes just weeks after Biocon announced that it had gained a certificate of good manufacturing practice from the European Medicines Agency’s Irish inspection authority for the Malaysian manufacturing site.
The setback also follows a previous CRL, in June 2018, for the follow-on insulin. In 2018, a Mylan representative told The Center for Biosimilars® that, “Following submission of our Insulin Glargine application under the 505(b)(2) regulatory pathway, we had agreed with FDA to provide additional clinical data in support of the manufacturing site change from Bangalore to Malaysia. Hence, the recent CRL was anticipated and built into our plan."
Prior to the initial CRL, the company received a Form 483 from the FDA, inclusive of 6 observations, after an inspection of the Malaysia facility. Another inspection of the site in June and July 2019 yielded another Form 483 with 12 observations.
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.
The product was authorized in these territories on the basis of data that included those from the phase 3 INSTRIDE 1 study in 558 patients with type 1 diabetes.1 The follow-on insulin was shown to be noninferior to its reference product in terms of change in glycated hemoglobin when administered once daily with mealtime insulin lispro. The follow-on was also shown to be well tolerated, and no new or significant safety issues were observed during the study.
Reference
Blevins TC, Barve A, Sun B, Ankersen M. Efficacy and safety of MYL-1501D vs insulin glargine in patients with type 1 diabetes after 52 weeks: results of the INSTRIDE 1 phase 3 study [published online April 15, 2018]. Diabetes Obes Metab. doi: 10.1111/dom.13322.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.