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Interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product

Interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product

5 Dec 2016

If approved, the product could provide blood cancer patients with access to potentially life-saving medicine.

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Smaller companies could carve out a sizeable niche in future influenza vaccines space

Smaller companies could carve out a sizeable niche in future influenza vaccines space

30 Nov 2016

New entrants, as well as smaller companies, will expand the use of cell culture-based manufacturing methods to increase their presence.

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Study confirms Sandoz biosimilar etanercept has equivalent efficacy to originator

Study confirms Sandoz biosimilar etanercept has equivalent efficacy to originator

27 Nov 2016

No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks.

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Sartorius Stedim Biotech opens new bioanalytical testing laboratory in Boston

Sartorius Stedim Biotech opens new bioanalytical testing laboratory in Boston

10 Nov 2016

New services to enable US biopharmaceutical companies to accelerate development of biosimilars.

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Increased development of highly-targeted biologics set to change composition of asthma therapeutics market

Increased development of highly-targeted biologics set to change composition of asthma therapeutics market

9 Nov 2016

Biologics and monoclonal antibodies to become a bigger presence within the small-molecule-dominated landscape.

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Mylan and Biocon announce FDA submission for proposed biosimilar trastuzumab

Mylan and Biocon announce FDA submission for proposed biosimilar trastuzumab

8 Nov 2016

Potential to be first submission of a proposed biosimilar trastuzumab in the US.

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EMA validates the MAA for avelumab for the treatment of metastatic Merkel cell carcinoma

EMA validates the MAA for avelumab for the treatment of metastatic Merkel cell carcinoma

31 Oct 2016

If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

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Boehringer Ingelheim's adalimumab biosimilar candidate shows promise

Boehringer Ingelheim's adalimumab biosimilar candidate shows promise

26 Oct 2016

Phase III study established equivalence in efficacy and similar safety profile between BI 695501 and Humira (adalimumab) in patients with active rheumatoid arthritis.

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Pfizer announces US availability of biosimilar Inflectra

Pfizer announces US availability of biosimilar Inflectra

21 Oct 2016

Inflectra will be the first biosimilar monoclonal antibody (mAb) to be available in the US.

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Merck Research Laboratories facilities designated as “Milestones in Microbiology” sites

Merck Research Laboratories facilities designated as “Milestones in Microbiology” sites

18 Oct 2016

Facilities chosen for their contributions to anti-infectives and vaccines.

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Pall Life Sciences wins BPI 2016 Best Downstream Application Award

Pall Life Sciences wins BPI 2016 Best Downstream Application Award

6 Oct 2016

Cadence Acoustic Separator system is a novel single-use solution for the clarification of cell culture bioprocess fluids.

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SSB launches two single-use Sartocon loop assemblies with integrated polyethersulfone membrane

SSB launches two single-use Sartocon loop assemblies with integrated polyethersulfone membrane

30 Sep 2016

Assemblies save up to 60% on processing time and offer a safe approach to ultrafiltration of biologics and vaccines.

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