Biosimilars

All articles by Biosimilars

Roche’s son-of-Rituxan scores priority review
Roche’s son-of-Rituxan scores priority review
Deborah Weinstein
July 3, 2013
2:29 pm

The FDA’s priority review for the Phase III chronic lymphocytic leukemia drug comes on top of Breakthrough Therapy designation, which the agent won in May.

EU backs Remicade biosimilars; anti-TNFs at risk
EU backs Remicade biosimilars; anti-TNFs at risk
Deborah Weinstein
July 1, 2013
4:23 pm

CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.

Sandoz readies Enbrel biosimilar for testing
Sandoz readies Enbrel biosimilar for testing
Deborah Weinstein
June 24, 2013
4:20 pm

The drug maker says it expects to use the Phase III clinical trial data to back applications in the EU and the US (when it gets a pathway setup).

Study shows old-school meds as effective as Enbrel
Study shows old-school meds as effective as Enbrel
Deborah Weinstein
June 12, 2013
4:22 pm

A cocktail of older meds works as well as Enbrel, a study found, but docs are already comfortable with prescribing the biologic and aren’t likely to switch therapies.

Roche’s Rituxan successor receives high marks
Roche’s Rituxan successor receives high marks
Kevin McCaffrey
May 16, 2013
5:39 pm

Genentech’s blockbuster follow-up shows promise in preliminary Phase III data

AbbVie reports first-ever quarter, downplays Pfizer impact
AbbVie reports first-ever quarter, downplays Pfizer impact
Deborah Weinstein
April 26, 2013
5:11 pm

Humira led in sales and the company told analysts Pfizer’s Xeljanz setback in Europe won’t alter its RA future all that much.

Pharmas to biotechs: let’s make a deal
Pharmas to biotechs: let’s make a deal
Matthew Arnold
April 25, 2013
8:51 pm

Having finally accepted that external R&D is the future, big pharmas are snapping up earlier-stage biotechs and biologics, but they’re not betting the farm on them, thanks to pre-nup-like earnout deals.

Amgen sales up for the quarter, but biosimilars grab buzz
Amgen sales up for the quarter, but biosimilars grab buzz
Deborah Weinstein
April 24, 2013
4:56 pm

Company revenues were up 5% over last year for the quarter, but much of the Q&A chatter centered around biosimilars.

Q&A: BIO’s Jim Greenwood
Q&A: BIO’s Jim Greenwood
Matthew Arnold
April 22, 2013
8:26 pm

BIO chief Jim Greenwood talks policy priorities and previews the group’s International Convention, now underway in Chicago.

Business Briefs: AstraZeneca, Amgen, BMS and Merck
Business Briefs: AstraZeneca, Amgen, BMS and Merck
April 18, 2013
3:21 pm

AstraZeneca cuts a deal with OCB to test unnamed cancer drug; an Enbrel biosimilar launches in India; BMS and Santaris seal an mRNA tech deal; Merck expands its China presence; Alzheimer’s advocacy group parents a spin-off.

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