Biocon’s breast cancer biosimilar gets a positive EMA opinion; closer to launching therapy in EU

Biocon Biologics’ pertuzumab biosimilar has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), bringing the Bengaluru-based company closer to launching the cancer therapy in the European Union.

The product, to be marketed under the brand name Pebrilzo®, is a 420 mg concentrate solution for infusion and is intended for the treatment of HER2-positive breast cancer across multiple stages of the disease. The CHMP recommendation follows the review of a marketing authorisation application submitted by Biocon Biologics Ireland, an indirect wholly owned subsidiary of Biocon Biologics.

MUST READ | India’s first dengue vaccine is coming: Dr Reddy’s ties up with Japan’s Takeda 

The recommendation is significant for Biocon because Pebrilzo is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA’s tailored clinical development approach, according to the company.

In simple terms, a biosimilar is a biological medicine that is highly similar to an already approved biological drug, with no meaningful differences in its quality, safety, or effectiveness. Biocon said its application included detailed laboratory studies and clinical data comparing Pebrilzo with the original medicine. The company said the studies showed that the two products were highly similar, with no clinically meaningful differences in quality, safety, or efficacy.

DON'T MISS | Can an eye drop replace reading glasses for 8 hours? Can it create a new drug market?

“The positive CHMP opinion for our Pertuzumab biosimilar marks an important step toward expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe,” said Shreehas Tambe, CEO and managing director, Biocon.

He added that the recommendation reflects greater regulatory confidence in using detailed laboratory and clinical data to establish that a biosimilar is comparable to the original biological medicine.

MUST READ | GLP-1 market may be smaller than expected, says Lupin; plans next wave of weight-loss drugs

Pertuzumab is a biological drug used to treat certain types of breast cancer in which cancer cells have high levels of a protein called HER2. Pebrilzo is proposed for use with trastuzumab and chemotherapy in adults with HER2-positive locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence. It is also proposed for use with trastuzumab and docetaxel in certain patients with metastatic or locally recurrent breast cancer that cannot be treated with surgery.

The CHMP opinion does not amount to marketing authorisation in the European Union. The application will now move to the European Commission for its final review and decision. Until that decision is issued, Pebrilzo is not authorised for use in the EU.

DON'T MISS | India targets 35-40% domestic value addition in mobile phones, says MeitY Secretary S Krishnan

For Biocon, the regulatory milestone adds another product to its global biosimilars’ portfolio. The company said it has commercialised 12 biosimilar products and has a research and development pipeline of more than 20 biosimilar assets, along with GLP-1 peptides and other complex generics. It operates across more than 120 countries, with seven manufacturing sites and three R&D sites.

If approved by the European Commission, Pebrilzo will be able to move towards commercial launch in the EU, subject to the applicable regulatory and market requirements.