Markets & Regulations

Bio-Separation: Our outgoing editor looks back over 5 years

13-Apr-2018 By Dan Stanton

Biopharma-Reporter editor Dan Stanton is finally packing his buffer bag and moving upstream.

Mylan to commercialise Fujifilm’s Humira biosimilar in Europe

11-Apr-2018 By Staff Reporter

Fujifilim Kyowa Kirin Biologics has teamed up with Mylan for the commercialisation of its Humira (adalimumab) biosimilar, FKB327.

Settled lawsuit paves way for Humira biosimilar in EU from October

06-Apr-2018 By Staff Reporter

The first Humira (adalimumab) biosimilar could be available in Europe by October after Samsung Bioepis settled a lawsuit with AbbVie.

UPDATE

Plant issues plague Celltrion and Teva as FDA issues two biosimilars CRLs

05-Apr-2018 By Dan Stanton

The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.

Kite founder’s new firm inks off-the-shelf CAR T deal with Pfizer

03-Apr-2018 By Dan Stanton

Newly formed company Allogene Therapeutics has teamed with Pfizer to develop allogeneic CAR T-cell therapies.

Shire share price jumps on potential Takeda bid

28-Mar-2018 By Dan Stanton

The acquisition of Shire would make Takeda a leader in rare diseases, bolster pipelines, and realign geographical focus, the Japanese biopharma says.

Takeda’s off-the-shelf stem cell therapy approved in Europe

27-Mar-2018 By Dan Stanton

Alofisel (darvadstrocel) has become the first allogeneic stem cell product to be approved in Europe.

Positively Europe: Thumbs up for Amgen, Sandoz biosimilars

27-Mar-2018 By Dan Stanton

The EMA has recommended the approvals of a third Herceptin (trastuzumab) biosimilar made by Amgen and Sandoz’s version of Remicade (infliximab).

Mundipharma goes up against MSD with Herceptin biosimilar in Europe

20-Mar-2018 By Dan Stanton

Mundipharma says it is not concerned at arriving second to market with a trastuzumab biosimilar after inking a deal to commercialise Celltrion’s Herzuma in seven European countries.

Pfenex hunting partners to advance Lucentis and Neulasta biosimilar candidates

16-Mar-2018 By Dan Stanton

Pfenex says it is actively looking for partners for its Lucentis and Neulasta biosimilar programmes, which are presently on hold.

First Herceptin biosimilar launched in UK

09-Mar-2018 By Staff Reporter

Merck & Co. will take on Roche as Ontruzant becomes the first biosimilar of cancer drug Herceptin (trastuzumab) to be launched in Europe.

BIOPHARMA AMBITION 2018

Irish government develops national policy to drive biosimilar use

06-Mar-2018 By Flora Southey

Ireland’s National Biosimilar Medicines Policy aims to increase biosimilar use and ‘drive down’ the cost of medicines, says government representative.

Russia's Biocad shifting all biomanufacturing to EU

27-Feb-2018 By Dan Stanton

Biocad says from 2021 all its biologic products will be made in the Europe Union, including its recently approved infliximab biosimilar.

Avid offloads Phase III mAb, becomes pureplay CDMO

20-Feb-2018 By Staff Reporter

Massachusetts-based Oncologie has agreed to buy Avid Bioservices’ bavituximab in a deal worth up to $103m.

MSD repurposing dormant Irish site and hiring 350 to support Keytruda

14-Feb-2018 By Dan Stanton

Merck Sharp & Dohme (MSD) plans to build a biologics facility at a former small molecule manufacturing site in Swords, Ireland, which it closed last year.