Alkem Laboratories Limited, a leading Indian pharmaceutical company, has made a significant stride in the treatment of HER2-positive breast cancer with the launch of Pertuza, a pertuzumab biosimilar, in India. This move not only expands Alkem's oncology portfolio but also aims to improve accessibility to critical cancer treatments in the Indian pharmaceutical market.

Breakthrough in Breast Cancer Treatment

Pertuza, an indigenously-developed and manufactured biosimilar of pertuzumab, is designed for the treatment of HER2-positive breast cancer. This launch is particularly noteworthy as breast cancer remains the most common cancer among Indian women, with accessibility to advanced treatments like pertuzumab being a significant challenge due to cost barriers.

Clinical Efficacy and Regulatory Compliance

Alkem's pertuzumab biosimilar has demonstrated its efficacy and safety through rigorous clinical trials. In a pivotal phase 3 clinical trial, Pertuza showed equivalence in efficacy, safety, and immunogenicity to the reference product of the innovator. This adherence to global standards underscores Alkem's commitment to providing high-quality, trusted scientific solutions.

Improving Accessibility and Affordability

Dr. Vikas Gupta, Chief Executive Officer of Alkem, emphasized the company's mission, stating, "Oncology is a priority area for Alkem, and our efforts are focused on developing treatment options that combine scientific excellence with wider access. The launch of Pertuza reflects this commitment and further strengthens our oncology portfolio."

By introducing an affordable pertuzumab biosimilar, Alkem aims to make this critical therapy available to thousands of women each year who would otherwise be excluded due to cost constraints.

Expanding Oncology Portfolio

The launch of Pertuza is part of Alkem's broader strategy to strengthen its presence in the oncology sector. The company's growing portfolio of oncology drugs includes other key products such as:

• Cetuximab biosimilar
• Denosumab biosimilar
• Bevacizumab biosimilar
• Romiplostim biosimilar

Company Profile

Alkem Laboratories Ltd., with a 50-year legacy, stands as the fifth largest pharmaceutical company in the Indian market. The company has a dominant position in various therapy areas, including anti-infectives, gastrointestinal, pain management drugs, and supplements. Alkem also boasts a growing portfolio in chronic therapies such as diabetes, neurology, cardiology, dermatology, and urology.

With 19 state-of-the-art manufacturing facilities and advanced R&D centers across India and the US, Alkem is well-positioned to develop and manufacture generic formulations, active pharmaceutical ingredients (APIs), and biosimilars.

The launch of Pertuza aligns with Alkem's core value of "Inspiring Healthier Lives," reinforcing its commitment to global health improvement and expanding access to critical medications in the Indian healthcare landscape.