Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).
Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a research grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).
Alvotech Receives CRL
For the third time in 2023, Alvotech received a CRL, this time for an ustekinumab product (AVT04). The news comes after Alvotech received 2 CRLs for its adalimumab biosimilar candidate.
The company said the letter was expected given the issues cited in the previous ones. All 3 CRLs have concerned the FDA inspection of Alvotech’s Reykjavik, Iceland, manufacturing facility. The FDA did not raise any issues with the adalimumab or ustekinumab products themselves nor the data packages submitted as part of the biologics license applications (BLAs).
Similar to the response to the CRLs for the adalimumab biosimilar, Alvotech said that it plans to resubmit and will address the FDA’s concerns. The resubmission will likely trigger a 6-month review period and a new Biosimilar User Fee Act goal date, pushing back the company’s original anticipated date for approval.
“AVT04 has recently been approved in Japan, and other marketing applications for AVT04 are currently awaiting approval in other major markets. Based on our latest interactions with the FDA, we are currently expecting that the agency will reinspect our facility in the beginning of next year. We look forward to being able to bring AVT04 to US patients, pending a satisfactory inspection and BLA approval, no later than in February 2025, in accordance with our license entry date agreement,” said Robert Wessman, chairman and CEO of Alvotech.
Cimerli Gains 25% of Ranibizumab Market
Formycon and its partner Coherus Biosciences announced that sales of Cimerli (ranibizumab-eqrn) have surpassed 100,000 doses since its October 2022 launch and the product has achieved 25% market share.
Cimerli was the first ranibizumab to receive FDA approval, and it was the first ophthalmology biosimilar to receive an interchangeability designation. The biosimilar references Lucentis and is used to treat age-related macular degeneration, macular edema, and diabetic retinopathy.
“This is a great achievement and underlines again that biosimilars are an important treatment option for severe retinal diseases,” commented Stefan Glombitza, PharmD, CEO of Formycon AG.
FDA Awards Grant to BBCIC
The FDA awarded the BBCIC a $1.4 million grant to enable biosimilar research. This grant will fund a new BBCIC study that will identify opportunities and challenges in using foreign real-world data to accelerate the approval process for biosimilars.
The Academy of Managed Care Pharmacy established the BBCIC in 2015 to address needs for more evidence for novel biologics, biosimilars, and other related products.
The study will assess real-world data from the United States, Italy, and Denmark to create recommendations for the FDA on how to address issues regarding the use of international data in its regulatory decision-making process for biosimilars. The primary investigators are 2 professors: 1 from the University of Verona and 1 from the University of Southern Denmark.
“The current approval process for biosimilar products is complex, delaying patients’ access to cost-effective therapies," said Cate Lockhart, executive director of the BBCIC. "Using real-world data from foreign countries could help improve the FDA’s work and ultimately help patients receive access to approved therapies in a timelier manner. We’re proud that the FDA has awarded BBCIC this grant to fund our study, which aligns with the FDA’s mission to make safe and effective drugs available to patients nationwide."
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability
April 30th 2024During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
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.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability
April 30th 2024During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
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.
2 Commerce Drive
Cranbury, NJ 08512