Enzene gets DCGI nod for biosimilar drug to treat haematological disorder

The company now has three biosimilars including the Denosumab biosimilar drug for osteoporosis and has some more in the pipeline. (Representative image)

Biotech company Enzene Biosciences has received approval from the Drug Controller General of India for its biosimilar drug Romiplostim in India. This drug is for the treatment of chronic immune thrombocytopenic purpura (ITP), a haematological disorder causing low platelet count and increased tendency to bleed and bruise, said Himanshu Gadgil, whole-time director and chief scientific officer of Enzene.

The symptoms of this disorder ranges from mild skin bleeding and bruises to potentially fatal internal bleeding, such as in the gastrointestinal tract and the brain.

Based in Pune, Enzene is a subsidiary of Alkem Laboratories. Enzene is focused on biosimilars, phytopharmaceuticals and synthetic peptides with its continuous biologics manufacturing facility in Chakan. This is an automated continuous cGMP compliant manufacturing plant for monoclonal antibody production.

According to Gadgil, with a global incidence rate of 6.4 per 100,000 children/year and 3.3 per 100,000 adults/year, primary chronic immune thrombocytopenia is considered a rare disease. It has to be managed by restoring platelet count and activity. Treatment of the disease (small molecule Eltrombopag) was available but access to these medicines in several developing nations like India was limited, Gadgil said.

The drug Nplate was first launched by Amgen in 2008 and it is a biologic drug which is developed by the complex genetic engineering process of recombinant DNA technology. Amgen’s Nplate was never launched in the subcontinent. In India, access to Romiplostim was virtually unheard of until 2019 when Intas Pharmaceuticals launched its biosimilar version of the 250 mcg dosage strength of the drug. Now Enzene has developed this biosimilar product.

Biopharmaceutical companies are hesitant in developing and manufacturing drugs for treatment of rare diseases because of a perceived lower commercial value compared with the highly complex processes associated with biologics, points out Gadgil.

The only way to make the drug affordable and accessible to patients from all economic and social backgrounds was through further biosimilarisation so Enzene has focused on it. As of 2021, Enzene Biosciences is the only company, which has launched all thee dosage strengths (125 mcg, 250 mcg and 500 mcg) of the drug to make it affordable and ensure widespread access to these therapies. Enzene is looking at expanding access to this drug across the globe through licensing and supply agreements, and strategic partnerships

The company now has three biosimilars including the Denosumab biosimilar drug for osteoporosis and has some more in the pipeline.