Intas said it is undertaking a detailed analysis on reports of inflammation and has advised doctors to avoid using the product, meant to treat an age-related eye condition, from this specific batch.
Intas Pharmaceutical, the Ahmedabad-headquartered drugmaker, has recalled a batch of its drug Razumab, a biosimilar version of ranibizumab, after several patients complained about inflammation in their eyes.
Razumab is the biosimilar version of ranibizumab, which is marketed by Novartis under the brand Lucentis in India. It is used for treatment of age-related macular degeneration (AMD), a common eye condition that causes vision loss among people age 50 and older.
Vitreo Retina Society of India (VRSI), the 600-member group comprising 90 percent of the country's Vitreo-Retina specialists, issued an alert on the drug on March 18 after some patients complained about discomfort.
VRSI has also called for an inquiry, seeking inputs from Intas and doctors.
The preliminary report found that out of 824 vials released to stockists, 435 vials were purchased by doctors and hospitals. Around 182 out of 435 vials were administered to patients.
“Total 11 eyes from 5 centres out of 182 injections have officially reported inflammation,” VRSI preliminary report said.
The report added that all the patients were treated with topical and oral steroids.
Moneycontrol accessed a copy of the report.
Intas advised doctors to stop using vials of the specific batch and later pulled that particular batch from the shelves. However, the other batches of Razumab have not reported any adverse reaction.
VRSI said it will share the final report with its members once the inquiry is completed.
“Intas is aware of few incidences of post injection inflammation reported pertaining to this specific batch which were managed by usual anti-inflammatory treatment,” an Intas spokesperson said in an email to Moneycontrol.
Intas said the reported incidences are well within the permissible limits.
According to the prescribing information of Lucentis, the reported incidence of ocular inflammation is 18 percent in patients treated for wet-AMD.
"Few patients getting such intravitreal injections are likely to experience such inflammation is reported in published data and pack insert of innovator Ranibizumab,” the company said. “We are extremely conscious of our product quality and are undertaking a detailed analysis of the same and have advised the doctors to avoid using the product from this specific batch."
Intas markets biosimilar version ranibizumab for debilitating eye complications of diabetes such as diabetic macular edema (DME) and diabetic retinopathy, where no other alternatives exist.
Intas’s Razumab received complaints of adverse reactions by doctors earlier as well and the company had to pull certain batches of the drug.
“We are the only biosimilar manufacturer in the world and market it as social responsibility to alleviate sufferings of such patients of our country. As a responsible organisation, we continuously strive to update the medical experts on the scientific aspects of our products and expected adverse events,” Intas said.
The company launched Razumab in India in June 2015 at 25 percent lesser price compared to Lucentis.Intas has plans to launch its version of ranibizumab in regulated markets such as US and Europe. The patents of ranibizumab expire in the United States in 2020 and in Europe in 2022. Meanwhile, Intas is launching the drug in other emerging markets through out-licensing partnerships.