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Eye on Pharma: Biocon Receives EU GMP Certification
Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.
Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.
A company spokesperson said in an email to The Center for Biosimilars® that “This was a surveillance inspection of our existing [drug product, DP] and [drug substance] facilities and a preapproval inspection of our additional DP manufacturing line. This certification will enable us to continue addressing the growing needs of patients in the EU markets and enhance access to our high-quality biosimilars.”
The Bengaluru facility is the site where Biocon manufactures its portfolio of biosimilar products, including the biosimilar products on which the company partners with fellow drug maker Mylan. The partnership is responsible for such FDA-approved biosimilars as Fulphila, a pegfilgrastim biosimilar that is already available in the US market, and Ogivri, a trastuzumab biosimilar expected to launch in 2019.
The Biocon and Mylan partnership also includes in-licensed adalimumab and etanercept products in the European marketplace, as well as several insulin biosimilars in various stages of development.
Biocon has also entered into a partnership with another biosimilar developer, Sandoz, for the development, manufacture, and commercialization of multiple, as yet undisclosed biosimilars targeting immunology and oncology indications.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
