Generic drugs mkt heat up as GLP-1 obesity meds demand soar

Generic version of Victoza has been approved in the U.S… the second approval after Teva's generic

GLP-1 generics, such as semaglutide·liraglutide, development continues

It has been reported that not only new drugs but also generics have joined the competition in the market for glucagon-like peptide-1 (GLP-1)- containing treatment for diabetes and obesity.

 

In the United States, generic versions of liraglutide, which is an active ingredient of the diabetes obesity·treatments Victoza·Saxenda that are GLP-1 receptor agonists.

 

In addition to the development of generic versions of liraglutide, generics of dulaglutide, an active ingredient of Trulicity, are under development.

 

Due to the benefits of effective weight loss with GLP-1 agonists, obesity treatment usage is significantly increasing.

 

Several GLP-1 agonists for treating obesity, including semaglutide and liraglutide, are in shortage worldwide.

 

The shortage in supply is due to a surge in demand for the drug.

 

Consequently, regulatory authorities expect that generic versions of diabetes·obesity drugs that are GLP-1 agonists will likely to resolve drug shortages.

 

The second diabetes drug containing liraglutide has been approved in the United States

Novo Nordisk

According to industry sources on December 30, the U.S.

 

Food and Drug Administration (FDA) has granted approval to a Victoza generic developed by a British pharmaceutical company, Hikma Pharmaceuticals.

 

This approval is the second for a generic GLP-1 agonist following Teva's generic for Victoza.

 

Teva Pharmaceuticals launched an authorized generic of Victoza after signing an agreement with Novo Nordisk.

 

Victoza is a GLP-1 agonist for diabetes treatment developed by Novo Nordisk.

 

It was first introduced to the market after obtaining approval in the United States in 2010.

 

After discovering the drug's weight loss effect during a clinical trial, Novo Nordisk introduced obesity drug containing the same active ingredient to the market in 2014.

 

Currently, GLP-1 agonist drugs, including liraglutide and semaglutide, are in global shortage.

 

Regulatory authorities, such as the FDA, have announced that they will prioritize the review of approval applications for generic versions of originals, which will resolve the issue of limited patient access.

 

The latecomers to the market anticipate gaining a market presence due to a surge in GLP-agonist demands.

 

These developers plan to challenge the market by introducing the drugs at lower prices than the originals.

 

Pre-launched Teva's Victoza generic is sold at a 15% lower price than the original drug.

 

Analysis suggests that not only latecomer new drugs but generics will continue to compete fiercely in the market, as GLP-1 agonists are demonstrating effectiveness in treating metabolism dysfunction-related MASH and brain diseases, in addition to diabetes and obesity.

 

Currently, GLP-1 agonist drugs are leading the market for diabetes and obesity treatments.

 

Lily's Mounjaro, a GLP-1 agonist for diabetes, recorded sales of KRW 6.8482 last year, up 971.2% from 2022.

 

The sales of Mounjaro, which was launched in May 2022 and generated the sales of KRW 640 billion in the same year, soared last year.

 

Novo Nordisk's GLP-1 agonist drugs for diabetes also showed growth last year.

 

Ozempic recorded sales of KRW 5.048 trillion last year, up 52% from the previous year.

 

The sales of Rybelsus, containing the same active ingredient, amounted to KRW 1.44 trillion, up 140% from 2022.

 

Saxenda generated sales of KRW 1.2252 trillion last year, up 9.8% from the previous year.

 

Despite the shortage, Wegovy exceeded KRW 300 billion in sales last year.

 

Pharmaceutical companies are closely watching the market for generic versions of GLP-1 agonists Korean companies are also closely watching the market for GLP-1 agonist generics.

 

Handok has successfully launched a generic version of Saxenda, developed by the Indian biotech company Biocon, in South Korea.

 

Both company signed an exclusive domestic sales·distribution agreements for Saxen generic in May.

 

Biocon obtained approval for its first generic of Saxenda in the UK in March and launched the drug this month.

 

Along with Biocon, the Indian companies Dr.

 

Reddy's and Cipla and the Swiss company Sandoz are developing a generic version of liraglutide for diabetes and obesity treatments.

 

Korean and overseas pharmaceutical companies are also focusing on semaglutide and dulaglutide, in addition to liraglutide.

 

Semaglutide is an active ingredient of Novo Nordisk's diabetes treatment, Ozempic, and obesity treatment Saxena.

 

Dulaglutide is an active ingredient of Lily's diabetes treatment Trulicity.

 

Wegovy·Zepbound·Saxenda, GLP-1 agonists for obesity

In June, the Chinese company Boan Biotech applied to the Chinese regulatory authority for approval of its generic version of Trulicity.

 

This represents the first approval application for a generic version of Trulicity.

 

Currently, generic versions of GLP-1 agonists for diabetes and obesity are continuing to be developed.

 

Last year, a Chinese company successfully received approval for its Saxenda generic.

 

Sam Chun Dang Pharm is targeting semaglutide generic.

 

In June, the company signed an exclusive sales agreement with a Japanese pharmaceutical company for an oral generic version of semaglutide.

 

The deal entails sales condition after the substance patent of semaglutide expires.

 

In Japan, semaglutide's substance patent expires in 2031.

 

Since 2018, Sam Chun Dang Pharm has been developing a generic version of liraglutide using its formulation-changing technology, called 'S-PASS.' Sam Chun Dang Pharm states that the company can avoid the formulation patent because it has been developing biosimilars and generics that avoid the patents of original formulations.

 

The company recently confirmed the drug equivalence through a pharmaceutical equivalence test.