Biocon's Pertuzumab gets EMA CHMP recommendation for breast cancer care
.webp)
Biocon Biologics’ Pertuzumab biosimilar has become the first monoclonal antibody biosimilar to receive a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) under the regulator’s new tailored clinical development approach.
The CHMP has recommended granting marketing authorisation for the drug, branded as Pebrilzo, for treating HER2-positive breast cancer across multiple stages of the disease, Biocon said in a press release on Monday.
The recommendation covers Pebrilzo as a 420 mg concentrate solution for infusion. The application was submitted by Biocon Biologics Ireland, an indirect wholly owned subsidiary of Biocon Biologics.
European Commission to take final call
The CHMP’s positive opinion is not the final marketing approval. The European Commission will now review the application and make a final decision.
If the Commission approves the application, the Summary of Product Characteristics will be made available in all official European Union languages. The European Public Assessment Report will also be published on the EMA website in the weeks following the decision, the press release said.
Until the European Commission grants marketing authorisation, Pebrilzo will not be authorised for use in the European Union, Biocon said.
What is Biocon’s Pertuzumab biosimilar?
Pebrilzo is a biosimilar medicine whose active substance is Pertuzumab, a monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2).
The drug is designed to inhibit the growth of tumour cells that overexpress HER2. It is indicated for use with Trastuzumab and chemotherapy in the neoadjuvant treatment of adults with HER2-positive locally advanced, inflammatory or early-stage breast cancer who are at high risk of recurrence, the press release said.
It is also indicated for adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
Biosimilarity established through analytical, clinical data
According to Biocon, the biosimilar underwent structural and functional analytical testing along with comparative clinical pharmacokinetic studies.
The company said the data showed that Pebrilzo is highly similar to the reference biologic, with no clinically meaningful differences in quality, safety or efficacy.
Shreehas Tambe, chief executive officer and managing director of Biocon, said the positive CHMP opinion was an important step towards expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe.
He also said the recommendation reflected greater regulatory confidence in using advanced analytical and clinical pharmacology evidence to establish biosimilarity.
Other Latest News
.webp)
The Supreme Court (SC) has reiterated that circulars issued by the Central Board of Direct Taxes (CBDT) are not binding on courts, while dismissing appeals by taxpayers seeking a deduction under Section 80HHC of the Income Tax Act, 1961, on premiums earned from the sale of export quotas, reported Live Law.
According to the report, a bench of Justices SVN Bhatti and NV Anjaria held that the premium received from the sale of export quotas could not be treated as income generated from exports because the transaction did not involve receipt of foreign exchange.
.webp)
India is selling more manufactured goods to China, with electronics emerging as a bright spot in a trade relationship that remains overwhelmingly tilted in Beijing’s favor.
Indian exports to China rose almost 40% in the five months through August, an analysis of government data shows, with electronics and engineering goods among the biggest drivers.
.webp)
Maruti Suzuki India Ltd (MSIL) is targeting 1 million "green vehicle" sales - spanning CNG, hybrid and EV - this financial year, helped by structural tailwinds such as rising crude prices and the introduction of automatic transmission in CNG variants.
The car market leader, under its Auto Green Mission, on Friday launched automatic S-CNG variants of its popular car models - Swift, Dzire and Baleno.
.webp)
Cough syrup bottles may soon carry a prominent warning against their use in children below four years of age, with India’s drug regulator considering changes to the labelling requirements for such medicines, The Economic Times reported on Saturday.
The proposal, which has been placed before the Drugs Consultative Committee (DCC), calls for the warning to be displayed in red on the bottle label.
.webp)
President Donald Trump on Friday signed into law a Russia sanctions bill that now empowers him to impose tariffs on countries that purchase Russian petroleum products.
The new sanctions authority has been eagerly anticipated by Ukrainian officials hoping for a tangible sign of US support in its fight against a Russian invasion. The war, now in its fifth year, is in a critical phase of escalation.
.webp)
.webp)
.webp)
.webp)
.webp)
