19:31 , Jul 14, 2017 |  BC Week In Review  |  Clinical News

FDA panel backs approval of Amgen's Avastin biosimilar

FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 17-0 in favor of approving ABP 215 from Amgen Inc. (NASDAQ:AMGN). The product is a biosimilar of Avastin bevacizumab from the Genentech Inc. unit of Roche (SIX:ROG;...
20:40 , Jul 7, 2017 |  BC Week In Review  |  Clinical News

India set to approve Biocad's biosimilar rituximab

Biocad CJSC (Saint Petersburg, Russia) said India’s Central Drugs Standard Control Organization (CDSCO) recommended approval of AcellBia (BCD-020), a biosimilar of rituximab. Biocad expects the product be approved next month, with a launch planned for...
22:31 , Dec 7, 2016 |  BC Week In Review  |  Clinical News

ABP 215 regulatory update

Amgen and Allergan said they submitted an MAA to EMA for ABP 215, a biosimilar of Avastin bevacizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland). The partners said they believe the...
07:00 , Oct 17, 2016 |  BC Week In Review  |  Clinical News

BCD-085: Phase II started

Biocad began a double-blind, placebo-controlled, international Phase II trial to evaluate 40, 80 and 120 mg subcutaneous BCD-085 at weeks 0, 1, 2, 4, 6, 8 and 10 in about 120 patients. Biocad CJSC, Saint...
07:00 , Jul 25, 2016 |  BioCentury  |  Strategy

Paving the way

Amgen Inc. and the Sandoz unit of Novartis AG are charting a course that could create competitive U.S. markets for two of the biggest prizes in the biosimilars universe, AbbVie Inc.'s Humira adalimumab and Amgen's...
08:00 , Dec 21, 2015 |  BC Week In Review  |  Clinical News

Bevacizumab biosimilar regulatory update

Biocad said Russia approved the company’s biosimilar of cancer drug Avastin bevacizumab. Biocad plans to launch the biosimilar next quarter and said it will be priced 30% less than the price of Avastin from...
08:00 , Dec 14, 2015 |  BioCentury  |  Emerging Company Profile

Subcutaneous solution

Subcutaneous delivery of biologics can eliminate or reduce visits to a hospital or doctor's office, but at the high concentrations required, an increase in interactions between the molecules causes most biologics to become too viscous...
07:00 , Jul 13, 2015 |  BioCentury  |  Finance

Big news

The performance of big cap biotechs has lagged that of companies one tier down, but the second half includes a host of milestones that could put the bellwethers on a steeper upward trajectory. Buysiders...
07:00 , Aug 18, 2014 |  BC Week In Review  |  Company News

Biocad, Millhouse, Pharmstandard deal

Pharmstandard and Russian investment firm Millhouse completed the acquisition of a combined 70% stake in Russian biosimilar play Biocad. Pharmstandard acquired a 20% stake and Millhouse acquired a 50% stake. Biocad founder and CEO Dmitri...
07:00 , May 26, 2014 |  BC Week In Review  |  Company News

Biocad, Pharmstandard, Millhouse LLC deal

Pharmstandard and Russian investment firm Millhouse are acquiring a combined 70% stake in Russian biosimilar play Biocad. Pharmstandard will acquire a 20% stake, while Millhouse will acquire a 50% stake. Biocad founder and CEO Dmitri...