India Pharma Outlook Team | Wednesday, 22 July 2026
Intas Pharmaceuticals has achieved a major milestone in India's breast cancer drug market. The company has received CDSCO approval to market its Trastuzumab Emtansine biosimilar in India.
The approval strengthens Intas' oncology portfolio. It also increases competition in the breast cancer drug market.
The therapy is approved for patients with early and advanced HER2-positive breast cancer who have previously received trastuzumab and taxane treatment.
The Ahmedabad-based drugmaker secured the approval after successfully completing a local Phase III clinical trial. The study evaluated the medicine's efficacy, safety, immunogenicity, and pharmacokinetics. The regulator has approved two intravenous strengths of the drug, 100 mg and 160 mg.
CDSCO has also directed the company to conduct a Phase IV study. The post-marketing study will further assess the medicine's safety and effectiveness in real-world clinical settings.
Breast cancer remains the most common cancer among women in India. Around 12% to 19% of breast cancer patients have HER2-positive disease. This subtype is considered one of the most aggressive forms.
Trastuzumab Emtansine is an antibody-drug conjugate. It combines trastuzumab with the chemotherapy agent emtansine. The medicine targets HER2-positive cancer cells directly. This approach helps slow tumor growth while reducing damage to healthy tissue.
The drug has shown strong clinical benefits in global studies. The KATHERINE trial found it reduced the risk of death by nearly half compared with standard trastuzumab in early-stage patients. The EMILIA trial reported a median progression-free survival of eight to nine months in advanced-stage breast cancer patients.
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The original therapy is sold by Roche under the brand name Kadcyla. The medicine generated more than $2.3 billion in global sales last year. This represented a seven percent increase from the previous year. India-specific sales figures have not been disclosed.
The expiry of Kadcyla's patent opened the market for biosimilar manufacturers. In 2021, Zydus Lifesciences became the first Indian company to launch a biosimilar version. It introduced the product under the brand name Ujvira.
The launch significantly lowered treatment costs. Ujvira was introduced at nearly Rs 32,000 for a 100 mg vial. Roche's innovator product had previously cost more than Rs 1.5 lakh for the same strength before patent protection expired.
Intas has not announced the commercial launch date or pricing of its biosimilar. However, the approval is expected to increase competition. It may also improve patient access to advanced HER2-targeted therapy in India.
Intas Pharmaceuticals is an Ahmedabad-based pharmaceutical company with a strong presence in oncology, biosimilars, and specialty medicines. The company operates in more than 85 countries and focuses on developing affordable, research-driven healthcare solutions.
