With over three decades of experience across India, ASEAN, and Australia, Deepali Naair brings deep expertise in brand building, marketing, and corporate reputation.
Biosimilars a huge opportunity, and also a challenge for Indian drugmakers
Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action
The US Food and Drug Administration (USFDA) has approved the company's first-to-file application for Yesafili, a vascular endothelial growth factor inhibitor used to treat several different types of ophthalmology conditions, the company said in a statement.
Biocon Biologics said that it has entered into a long-term commercial collaboration with Eris Lifesciences to expand patient access to its portfolio of Metabolics, Oncology, and Critical Care products in India.
After Biocon Biologics' formulation deal, net debt at the company is estimated to rise from Rs 886 crore to Rs 2,400 crore
As part of the deal over 430 employees associated with the business are expected to transition to Eris
The settlement pact paves the way for the introduction of Yesafili, a proposed biosimilar to Eeylea (aflibercept) injection, in the Canadian market, Biocon Biologics said in a regulatory filing.
The agreement provides Sandoz the exclusive rights to promote, sell and distribute biosimilars Trastuzumab and Bevacizumab in Australia, Biocon Biologics said in a statement.
Adalimumab BS for subcutaneous injection is a biosimilar of Humira, offering therapeutic solutions for immune-related diseases such as rheumatoid arthritis, psoriasis vulgaris, ankylosing spondylitis, Crohn's disease and ulcerative colitis
Earlier in 2023, the integration process included over 70 emerging markets in July, the North America business in September, and the European business in November
Eris Lifesciences has signed a definitive agreement with Biocon Biologics to acquire its Branded Formulations’ India (BFI) business units of nephrology and dermatology.
The deal will be funded partly through debt financing. The transaction is expected to achieve financial closure by the end of 2023.
Biocon Biologics, a fully integrated subsidiary of Biocon Ltd, focuses on making biosimilars, with key revenue-generating markets being the United States and Europe.
The US drug regulator issued 6 observations for Drug Substance, Drug Product units and Quality Control laboratories and 2 observations for the Delivery Devices unit.
Biocon Biologics had signed a deal to acquire Viatris Inc's biosimilars business for $3.33 billion in February 2022
Following the deal closure in November 2022, this marks the first wave of countries where Viatris' operations have fully transitioned to Biocon Biologics, the company said in a statement.
The company said HULIO (adalimumab) injection, a biosimilar to Humira (adalimumab), is now available to patients in the US after five years of experience in Europe and two years in Canada.
Ravi Dadhich, chief, Jan Aushadhi Yojana, said that the generic medical outlets under Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP) record Telmisartan, Amlodipine and Metformin among their top-selling drugs.
Tambe was Deputy CEO of Biocon Biologics, a subsidiary of Bengaluru-based Biocon.
In February this year, Biocon Biologics inked a pact to acquire Viatris Inc's biosimilars business for consideration of up to USD 3.33 billion (about Rs 24,990 crore).
Under the terms of this deal, Japan-based Yoshindo gets exclusive commercialisation rights in Japan for Ustekinumab and Denosumab -- developed and manufactured by Biocon Biologics -- for an addressable market opportunity of USD 700 million, Biocon Biologics said in a statement.
The Japanese pharma firm will get an exclusive commercialization right in Japan for two biosimilars developed by Biocon Biologics, for an addressable market opportunity of USD 700 million.
The court has allowed the Central Bureau of Investigation to collect voice sample specimens of all the five accused to compare them with the recorded conversations.
The court will also give its order on an application to test voice samples of all the arrested in a bribery scandal reportedly involving a joint senior executive of Biocon Biologics.