Shire has begun adding capability within its own network to manufacture the Hereditary Angioedema (HAE) product Cinryze, currently being made by Dutch CMO Sanquin.
update - WHO outlines biosimilarity requirements and inspection plan
The WHO has announced plans to extend its prequalification scheme to include cancer biosimilars and says it will pressure industry for fairer prices for all biologics.
The European Commission has urged UK Pharma firms to check how Brexit will impact their drugs, pointing out that EU law requires that authorisation holders have a base in a member state or EEA country.
The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.
Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the MHRA limit communication to essential information.
Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes.
American-made biosimilars hold no advantage in the US market according to patient and physician groups which place emphasis on trusted and reputable manufacturers instead.
Lonza's biopharma business grew faster than other divisions in 2016 with a drug firm becoming the Swiss life science supplier's biggest customer for the first time since 2013
The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.
Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?
The investment at the Gödöllö manufacturing site adds 104 jobs and comes a week before GSK breaks ground on a $170m meningitis B vaccine facility in Germany.
Biosimilar developers have welcomed a court ruling against AbbVie regarding Humira indication patents, but an IP lawyer warns the judgement is not binding outside the UK.
The US FDA has cleared Seattle Genetics to restart trials of its blood cancer candidate vadastuximab talirine that were halted last year after patient deaths.
Russia’s Ministry of Health has awarded Biocad marketing authorisation for a biosimilar version of EMD Serono’s Multiple sclerosis drug Rebif (interferon beta-1a).
The European Commission has approved Celltrion Healthcare’s rituximab biosimilar – Truxima (CT-P10) – for the same autoimmune disease and cancer indications as the reference product.
Rumours of an Irish expansion freeze have been greatly exaggerated according to Eli Lilly, which says it remains committed to its Kinsale biomanufacturing site.
Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.
If reinstated, Donald Trump’s order restricting travel to the US would hurt the cell therapy sector according to the International Society for Cellular Therapy (ISCT).
The promised jobs were always part of Amgen’s 2017 plans says CEO Robert Bradway, but a reduced US footprint means hiring more biomanufacturing staff is unlikely.
Sandoz withdrew its pegfilgrastim biosimilar application before responding to concerns about the lack of cGMP accreditation at the candidate’s manufacturing site, the EMA says.
Pfizer has resubmitted its antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) for regulatory review almost seven years after withdrawing it from the market.
Donald Trump’s withdrawal from the Trans-Pacific Partnership (TPP) could end up benefitting Asian biosimilar makers and reducing US jobs, says an IP lawyer.
Johnson & Johnson has predicted a 10-15% erosion in sales of Remicade (infliximab) in 2017 following Pfizer’s “at-risk biosimilar launch of Inflectra.”
Wuxi Biologics has confirmed its intention to go public in an IPO application that reveals the contracter has seen revenue double and profits increase three-fold since 2014.
