Alkem Laboratories launches Pertuza, a biosimilar drug to pertuzumab for treating HER2-positive breast cancer

Alkem Laboratories said on Monday that it has launched Pertuza, a highly similar (biosimilar) drug to Pertuzmab—a targeted cancer therapy—to treat HER-2 positive breast cancer.

Alkem’s Pertuza is an affordable, indigenously developed and manufactured biosimilar of pertuzumab. In the pivotal late-stage clinical trial, Alkem’s pertuzumab biosimilar, developed by its biotech subsidiary, demonstrated equivalence in efficacy, safety, and immunogenicity to the reference product of the innovator, which is sold under the brand name Perjeta by the Roche Group.

“Oncology is a priority area for Alkem, and our efforts are focused on developing treatment options that combine scientific excellence with wider access,” said Dr Vikas Gupta, chief executive officer, Alkem, in a statement. According to Dr Gupta, the launch of Pertuza reflects further strengthens the company’s oncology portfolio. “Alkem aims to make this critical therapy available to thousands of women each year who would otherwise be excluded,” said Dr Gupta.

A biosimilar drug is not an identical copy of the drug. It is a biological product that is highly similar to the reference product, which in this case, is Perjeta. In a biosimilar drug, it is implied that it must have the same mechanism of action, route of administration, dosage form, and strength. Most importantly, any biosimilar drug must demonstrate through rigorous testing that it has no clinically meaningful differences in terms of safety, purity, and potency when compared to the original drug.

Accessibility of pertuzumab in India has remained a significant challenge, and only a limited number of HER2-positive breast cancer patients can use it in their treatment due to cost barriers, according to Alkem, making the development of biosimilar drugs to pertuzumab, providing a cheaper alternative to the original drug, which could be out of reach to many.

Apart from Alkem, Zydus manufactures a pertuzumab biosimilar called Sigrima, which is co-marketed with Dr Reddy’s under the brand Womab.

According to a note by ICICI Securities, Alkem CEO Gupta is targeting double-digit revenue growth in the medium term, driven by strong hold in India (68% of sales), other international markets and new ventures. In India, it aims to grow between 100 and 150 basis points faster than IPM, as focused chronic therapies are increasing at a faster pace, with adequate growth supported by the acute portfolio.

Alkem Laboratories shares closed 1% lower on Monday at ₹5,486 apiece.