Baxalta receives CHMP positive opinion for Sanquin to begin production, enhancing global supply of plasma-based therapies
![](/46/pdcnewsitem/03/82/47/baxalta.jpg)
Sanquin is now licensed to produce bulk material for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU) for the European Union, Iceland and Norway.
Baxalta Inc. has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion, licensing European production of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU) through Baxalta’s manufacturing services agreement with Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation or Sanquin) in the Netherlands. Both products are indicated to treat specific types of patients with primary immune deficiency.
Baxalta continues to optimize its manufacturing network to support increasing global demand for plasma–based therapies. The positive opinion from CHMP allows Sanquin to process plasma supplied by Baxalta into bulk material for HYQVIA and GAMMAGARD LIQUID 10% in the European markets. These additional manufacturing capabilities also allow Baxalta to optimize capacity at other facilities to serve other regions. Baxalta will continue to supply the US market from its FDA approved manufacturing sites in the US, Austria and Italy.
“Meeting the increasing demand for plasma-based therapies is a key component of our global manufacturing strategy,” said John Furey, senior vice president and head of Global Operations, Baxalta. “This CHMP positive opinion enables Baxalta to provide additional supply of critical plasma-based therapies by leveraging our manufacturing network and regional partners to optimize our flexibility and capacity.”
Previously, as Baxter International Inc.’s BioScience business, Baxalta entered into a manufacturing services agreement with Sanquin in July 2012. The agreement enables Baxalta to gradually ramp up to 1.6 million liters of incremental plasma fractionation capacity annually to support global growth of plasma-based treatments.
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance