As the patents on various weight-loss drugs near expiry, Indian and Chinese companies are racing to produce biosimilar versions, in efforts to widen affordable access to these remarkably effective treatments.
Nature reports that there is a long long queue of companies developing copies of the complex biological drugs, with a number of them vying to create modified or improved versions to compete in the global market, with its millions of obese and overweight people.
“There is huge potential for companies from India and China that can help create access to these,” said Abhijit Zutshi, chief commercial officer of the pharmaceutical giant Biocon, headquartered in Bengaluru, India, who oversees its generics business and is based in New Jersey USA.
These companies will “bring drugs to patients who need them, at a cost that can be afforded”, said Guy Rutter, a cell biologist at the University of Montreal in Canada.
Globally, 1bn people are obese or overweight – and hundreds of millions of them live in India and China, said Lei Qian, vice-president of clinical development at Innovent Biologics in Shanghai, China, who added that “demand for anti-obesity drugs is very strong” in a country where the number of overweight adults is projected to reach 540m by 2030, 2.8 times higher than 2000 levels, and the numbers who are obese are predicted to jump 7.5 times to 150m.
Hormone mimics
The treatments have taken the world by storm since the FDA approved the first class of GLP-1 drugs for weight loss in 2014.
The daily injection liraglutide, marketed as Saxenda by Denmark’s Novo Nordisk, can trigger an average body-weight loss of 8% after a year.
The next generation of these drugs required fewer injections and led to greater weight loss. In 2021, the FDA approved semaglutide, sold as Wegovy by Novo Nordisk, as a weight-loss treatment, and in 2023 it approved tirzepatide, marketed as Zepbound by Eli Lilly, based in Indianapolis, USA.
The weekly injections semaglutide and tirzepatide can induce an average body-weight reduction of between 12% and 18%. In addition to their slimming effects, these drugs are marketed under different brand names, like Ozempic, as treatments for type 2 diabetes.
Clinical trials have also shown that they can reduce the risk of kidney failure, tame inflammation and protect against serious heart problems.
Biosimilars bonanza
But the drugs are expensive: a month’s worth of semaglutide or tirzepatide injections can cost more than $1 000.
Indian and Chinese pharmaceutical companies plan to slash that price by developing biosimilars, cheaper versions of expensive brand-name drugs.
Unlike generics, which are exact copies of chemically synthesised branded drugs, biosimilars very closely resemble their reference product and are derived from modified living organisms, such as yeast.
Companies are preparing to release biosimilar versions of GLP-1 drugs when patent protections lift in different markets. In China, the patent for liraglutide has already expired, and the one for semaglutide will expire in 2026 in India and China.
Companies are also innovating in how they synthesise the drugs, fill the vials and manufacture the injection devices, said Zutshi, whose company is focusing on developing biosimilars for the global market.
How much the cost will drop is yet to be seen, he added. It could be cut in half, or be one-tenth the current price. If drugs are cheaper, more people will use them, thus expanding demand, he said.
This, in turn, could have a “ripple effect” in which companies reduce the price of existing weight-loss drugs “in anticipation of the competition coming”.
No weight-loss biosimilars have yet been approved in India, but Glenmark Pharmaceuticals in Mumbai launched Lirafit, a liraglutide biosimilar, in January for treating type 2 diabetes. Glenmark said that at $1.20 a day, Lirafit costs 70% less than existing therapies.
Biocon has also developed a liraglutide biosimilar, which was approved by the UK drug regulator for type 2 diabetes in March but the product is not on the market yet.
Biocon said it was developing semaglutide biosimilars to launch in select countries as soon as 2026.
China’s drug administration has approved two GLP-1 drugs produced by Chinese companies for weight loss. The first is a liraglutide biosimilar marketed as Liluping, made by Huadong Medicine in Hangzhou. The second is beinaglutide, marketed as Feisumei by Benemae Pharmaceutical Corporation in Shanghai.
Several companies in China are ready to pounce on the semaglutide market as soon as the patents expire in 2026. Half a dozen companies have launched late-stage clinical trials of semaglutide injections. One of them, Hangzhou Jiuyuan Gene Engineering, has completed late-stage clinical trials for its semaglutide biosimilar for treatment of type 2 diabetes, and could be the first to enter the Chinese market.
A pending court decision on whether the semaglutide patent applies in China could see these drugs enter the market even sooner. (Novo is in a legal fight in the country over the patent, and an adverse ruling could make it lose its semaglutide exclusivity even sooner, making China the first major market where it is stripped of patent protection for the drugs).
Late-stage trials for the company’s semaglutide biosimilar targeting weight loss are expected to start this year.
The arrival of semaglutide biosimilars will be a “game changer” and competition “will be severe”, said Lei.
Improved drugs
Beyond biosimilars, companies in India and China are also developing new obesity drugs. For example, Mumbai-based Sun Pharmaceuticals has developed a molecule called GL0034 that has slight tweaks to its chemistry that distinguish it from semaglutide and alter the way it interacts with insulin-secreting cells and nerve cells, said Rutter, who is a consultant for the company.
“Not only is the ambition to have a cheaper product, but to have something which is as good as, if not better than, semaglutide.”
Early-stage clinical trials of GL0034 have been “very encouraging”, said Rajamannar Thennati, executive vice-president for Sun Pharma, who is based in Vadodara, India. The results in three dozen participants show that high doses can lead to body-weight reductions of up to 10% after two months, but Thennati said it could take up to five years for the molecule to hit the market.
Sun Pharma is also in the early stages of developing a dual-target drug to compete with tirzepatide. Its structure is sufficiently different to be proprietary, Rutter saud.
Another improved drug could arrive in the Chinese market even sooner. Innovent has partnered with Eli Lilly to develop a molecule called Mazdutide that mimics both GLP-1 and the glucagon hormone, which stimulates glucose production.
Glucagon helps to increase metabolism and enhances fatty-tissue burning.
Results from late-stage clinical trials for Mazdutide will be announced at the American Diabetes Association meeting in Florida next month. Lei said they are “positive”.
Preliminary data suggest some trial participants taking high doses lost about 19% of their body weight after close to a year. Lei expects that Mazdutide will be approved for weight loss by China’s drug regulator in the first half of 2025, which would make it the first of this class of dual-target drugs to be approved globally.
On Tuesday, reports Reuters, Novo Nordisk announced that Wegovy has been approved in China, but the group faces competition from rival Eli Lilly, whose diabetes drug tirzepatide received approval from China in May. It is expected that Zepbound, the US firm’s weight-loss drug with the same active ingredient, will be approved in China this year or in the first half of 2025.
Reuters article – Novo Nordisk's Wegovy weight-loss drug approved in China (Open access)
See more from MedicalBrief archives:
Costly Ozempic can be made for less than $5 month – UK study
Big Pharma under pressure over drugs shortages and high costs
Weight loss drug approved for heart disease prevention
Eli Lilly tightens diabetes drug access, frustrates obese patients
Tirzepatide beats semaglutide in glucose control, weight loss