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FDA should expect more submissions as US biosimilar doors open, says consultant

Sandoz’s recommendation was an “inevitable step” in the introduction of biosimilars to the US, and the US FDA should expect more submissions according to a consultant.

Australia doubles back on biosimilar naming conventions to follow WHO move

Australia’s TGA (Therapeutic Goods Administration) is shifting its stance on the way it plans to name biosimilars to keep the country more in line with the WHO’s (World Health Organization) proposed policies.

Pre-competitive groups don't compete; Amgen and Lundbeck join group behind the HELM platform

Competition is not a problem in the pre-competitive collaboration space according to the Pistoia Alliance, a non-profit R&D innovation focused group that has signed up Amgen and Lundbeck as its latest members.

Teva: More biomanufacturing space needed to tap biologics opportunities

Teva must invest in its biomanufacturing network as the firm’s biologics aspirations grow beyond biosimilars, CEO Erez Vigodman told investors.

Biosimilar mAbs may have tougher time winning US FDA approval says expert

So far most biosimilars filed in the US have been ‘low risk’ according to contractor BioOutsource, which warned that developers seeking approval for copycat mAbs face higher legal and regulatory hurdles.

Spotlight

Biopharma's margins can withstand Capex increases after tech sector M&As, expert

Biopharma's margins can withstand Capex increases after tech sector M&As, expert

High margins mean biopharmas can absorb technology price increases after a year of supplier consolidation according to...

Immunotherapy in the UK? National manufacturing site backed by GE

Immunotherapy in the UK? National manufacturing site backed by GE

GE Healthcare has pledged its support and technology to a national £55m ($86m) Cell Therapy manufacturing centre...

Baxter exits vaccines business as it preps for biopharma spinout

Baxter exits vaccines business as it preps for biopharma spinout

Baxter has sold its pandemic flu portfolio and Vero cell technology to Nanotherapeutics in preparation for the...

Singapore develops plan to support influx of biomanufacturing

Singapore develops plan to support influx of biomanufacturing

Industry heavyweights and Singaporean development groups have unveiled a five-year roadmap to deal with the need for...

AstraZeneca shutting asthma drug plant as pipeline shifts to biologics

AstraZeneca shutting asthma drug plant as pipeline shifts to biologics

AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline,...

Harvard scientists develop new material to help deliver 3D vaccines

Harvard, Korean scientists develop new material to help deliver 3D vaccines

Korean and Harvard University scientists have developed a way to non–surgically inject programmable biomaterial to deliver a...

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