In early June 2021, US Food and Drug Administration (FDA) approved Natco Pharma’s abbreviated new drug application (ANDA) for carfilzomib vials, a generic version of anticancer drug Kyprolis. It also accepted Lannett’s ANDA for their generic version of asthma treatment Adavir Diskus, fluticasone propionate and salmeterol inhalation powder.
Natco cancer generic approval
Indian pharmaceutical company, Natco Pharma has developed a carfilzomib generic and the ANDA was submitted by their marketing partner, Respirent Pharmaceuticals Co Ltd. In the company’s June announcement, the 10 mg and 60 mg strengths of the product have received final approval from the regulator, and the 30 mg strength, a tentative approval. In the press release, Natco stated that it is eligible for 180 days of sole generics marketing exclusivity for the 10 mg strength and shared 180 days of generic marketing exclusivity for the 60 mg strength of the product when it is launched.
Originally developed by Onyx Therapeutics, carfilzomib is a multiple myeloma treatment [1]. In 2019, Natco and Breckenridge reached a settlement agreement with Onyx and, as part of this, were granted a license permitting launch of their generic carfilzomib products.
Natco hopes to launch the newly approved product by 2027. This will enable it to tap into the large Kyprolis market, which generated annual sales of US$696 million during the 12 months ended December 2020 in the US.
The launch of this product and others in the US, is predicted to contribute to strong growth for Natco in 2021. Despite being impacted by the COVID-19 pandemic, the company achieved 6.6% year-on-year increase between the year ending March 2020, and that ending 2021.
Lannett generic and biosimilar advances
US-based Lannett’s fluticasone propionate and salmeterol inhalation powder was produced as part of its strategic alliance with Respirent Pharmaceuticals Co Ltd. Under this agreement, Lannett will distribute the asthma treatment product in the US and receive a portion of the profits. At present this agreement is set to continue for 12 years following the start of distribution.
Lannett’s generic version of GlaxoSmithKline’s (GSK) originator hopes to tap into the Advair Diskus market, which was approximately US$3 billion for the 12 months ending April 2021. The ANDA was made for 100/50 mcg, 250/50 mcg and 500/50 mcg doses.
Lannett is also making progress with another respiratory product, a generic version of GSK product, Flovent Diskus (Fluticasone Propionate Powder Inhaler).
In addition, there is advancement with two biosimilar products for the treatment of diabetes, biosimilar insulin glargine and biosimilar insulin aspart. Biosimilar insulin glargine is being developed together with their strategic partner in China, Yichang HEC Changjiang Pharmaceutical (Yichang), which is part of the HEC Group [2]. This product is particularly promising, and the company hope to commence the application process by the end of 2021; and see a potential launch in 2023.
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Lannett starts phase I trial for insulin glargine biosimilar in South Africa
FDA approves generics from Amneal and Dr Reddys and Natco submits ANDA
Aurobindo and Lannett expand their generics portfolios
UCB sells generics unit to Lannett
References
1. GaBI Online - Generics and Biosimilars Initiative. Dr Reddy’s expands collaboration with Amgen in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 25]. Available from: www.gabionline.net/Pharma-News/Dr-Reddy-s-expands-collaboration-with-Amgen-in-India
2. Lannett to co-develop biosimilar insulin product with Chinese partner [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 25]. Available from: www.gabionline.net/Pharma-News/Lannett-to-co-develop-biosimilar-insulin-product-with-Chinese-partner
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