Brazil rejects Dr Reddy's, Cipla GLP-1 generics on technical grounds

Brazil's regulator Anvisa rejects DRL and Cipla's generic GLP-1 drug filings, citing unmet technical requirements on efficacy, safety and quality

Brazilian health regulatory body Anvisa has rejected the registration request of Dr Reddy’s Laboratories' (DRL’s) generic semaglutide version Embeltah on technical grounds.

 

“In practice, this means that the requests did not meet all the technical requirements for proving the efficacy, safety, and quality of the products,” according to an update on the Anvisa website.

 

The regulatory body also rejected registration of two liraglutide generics (Plaobes and Lirahyp) from Cipla on the same grounds. Both semaglutide and liraglutide are glucagon-like peptide (GLP-1) receptor agonists, which are used in the treatment of Type 2 diabetes and weight management.

 

The rejection comes at a time when DRL’s semaglutide launch is also stuck in Canada after the country's health regulator sent the company a Notice of Non-Compliance (NoN) over technical queries.

   

“We are working with regulatory authorities in Brazil and Canada, and we remain committed to bringing the generic semaglutide product to these markets upon approval,” DRL said in response to queries sent by Business Standard.

 

The drugmaker had last week informed the exchanges that it had received drug identification numbers (DINs) for semaglutide injection from Health Canada on April 22, 2026.

 

The rush to launch generic versions of semaglutide comes at a time when Danish drugmaker Novo Nordisk started to lose exclusivity for the drug in major markets since the start of 2026.

 

Canada was the first major Western country to have semaglutide lose exclusivity on January 4 this year, with DRL aiming to be among the first launches in the market. According to market research firm IQVIA, the Canadian semaglutide market was valued at approximately $1.18 billion in 2024 and is projected to reach over $4 billion by 2035.

 

The semaglutide patent in Brazil expired on March 20, the same day as in India. The market for the drug is expected to grow from $250 million in 2024 to over $880 million by 2035, according to a report by Grand View Research.