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FDA Receives First-Ever Biosimilar Application for Monoclonal Antibody - Regulatory Focus

FDA Receives First-Ever Biosimilar Application for Monoclonal Antibody - Regulatory Focus | Immunology and Biotherapies | Scoop.it
Regulatory Focus FDA Receives First-Ever Biosimilar Application for Monoclonal Antibody Regulatory Focus The company's biosimilar filing is the second-ever filing of a drug through FDA's new 351(k) biosimilar pathway, and reportedly the first-ever...
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Producing Vaccines, biologics and monoclonal antibodies from Plants. Medicago

Producing Vaccines, biologics and monoclonal antibodies from Plants. Medicago | Immunology and Biotherapies | Scoop.it

 

 Why VLPs? For effective, long-lasting vaccines

Virus-Like Particles (VLPs) represent one of the most exciting emerging vaccine technologies for generating effective and long-lasting protection. VLPs consist of  protein shells studded with short strands of the proteins specific to whatever disease the vaccine is intended to control. VLPs are made to look like a virus, allowing them to be recognized readily by the body's immune system, however, they lack the core genetic material, making them non-infectious and unable to replicate. Unlike current influenza vaccines that are manufactured with an inactivated virus, VLP-based vaccines do no require an actual sample of the virus, they simply require the genetic sequence of the virus or bacteria. 

Another important advantage of VLPs is that they more effectively activate key aspects of the immune response to achieve potent immune stimulation and to provide immunological memory. VLP-based vaccines have also shown to provide protection against different strains of a virus other than those for which the vaccine was formulated. With influenza viruses mutating rapidly, the previous years vaccines produced in eggs often cannot be used. Medicago's VLP technology enables the creation of a vaccine that exactly matches the specific pandemic strain in circulation and offers strong cross-protection against other subtypes of influenza.

 

Medicago’s transient expression manufacturing platform, Proficia™, has been developed and optimized for use with Nicotiana benthamiana – a relative of the tobacco plant. The leaves of these plants are well suited to rapidly incorporate, in a non-permanent fashion, the genetic information required to produce high yields of VLPs. Thanks to the extensive experience accumulated on tobacco cultivation, scale-up and maintenance costs are relatively low. Furthermore, because fully grown plants are used, no potentially time-consuming crop development steps are necessary. By using plants in general, costs associated with infrastructure and raw materials are lower, and the risk of viral contaminants from animal sources is substantially reduced.
We have also developed a technology for the production of recombinant proteins in transgenic alfalfa. Transgenic alfalfa is best suited for the production of recombinant proteins required in high volumes and for which a relatively long lead time – up to six months – is not an issue. While this technology is not suited for the production of vaccines, we believe it may have applications in other fields of interest such as the production of biosimilars.

  


Via Krishan Maggon
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Krishan Maggon 's curator insight, August 17, 7:10 AM

 Companies and academic labs are pursuing it to create medicines and vaccines against such targets as HIV, cancer, the deadly Marburg virus and norovirus, known for causing outbreaks of stomach bug on cruise ships, as well as Ebola.

 

ELELYSO is the first FDA-approved, plant cell-based ERT indicated for the treatment of Type 1 Gaucher disease.  It was developed by Israel  company Protalix and licensed to Pfizer.

 

ELELYSO™ (taliglucerase alfa, Pfizer) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease and was approved by the United States (U.S.) Food and Drug Administration (FDA) on May 1, 2012.

 

ZMAPP the Ebola mab is produced in Tobacco plants by MAPP Pharma.

 

 

 

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Structural Analysis of an Intact Monoclonal Antibody by Online Electrochemical Reduction of Disulfide Bonds and Fourier Transform Ion Cyclotron Resonance Mass Spectrometry - Analytical Chemistry (A...

Structural Analysis of an Intact Monoclonal Antibody by Online Electrochemical Reduction of Disulfide Bonds and Fourier Transform Ion Cyclotron Resonance Mass Spectrometry - Analytical Chemistry (A... | Immunology and Biotherapies | Scoop.it
Structural Analysis Intact Monoclonal Antibody by Online EC Reduction Disulfide Bonds & FTICR MS #mAbs #biosimilars
http://t.co/kjwLkWitLM
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market - The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth. - Bi

Monoclonal Antibodies Key to Unlocking the Biosimilars Market - The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth. - Bi | Immunology and Biotherapies | Scoop.it
The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth. (Approval of monoclonal antibody #biosimilars is necessary if the biosimilars market is to experience real growth.
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World’s first biosimilar antibody is approved in Korea

World’s first biosimilar antibody is approved in Korea | Immunology and Biotherapies | Scoop.it
World’s first biosimilar antibody* is approved in Korea celltrion Worlds first biosimilar antibody* is approved in Korea South Korean biosimilar manufacturer Celltrion, today declared that, Korean Food and Drug Administration approved its...
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GEN | Insight & Intelligence™: Biosimilars: 11 Drugs to Watch

GEN | Insight & Intelligence™: Biosimilars: 11 Drugs to Watch | Immunology and Biotherapies | Scoop.it
If imitation is the sincerest form of flattery, these innovator drugs should be blushing.
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market - The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth. - Bi

Monoclonal Antibodies Key to Unlocking the Biosimilars Market - The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth. - Bi | Immunology and Biotherapies | Scoop.it
The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth. (Approval/acceptance of monoclonal antibody biosimilars is necessary for biosimilars market to experience real growth.
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Biological Medicines And Biosimilars - Mondaq News Alerts (registration)

Biological Medicines And Biosimilars - Mondaq News Alerts (registration) | Immunology and Biotherapies | Scoop.it
Biological Medicines And Biosimilars Mondaq News Alerts (registration) A watershed moment was seen in September 2013 with the grant by the European Commission of marketing authorisations throughout the European Union for the first two biosimilar...
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More clarity for complex biosimilars: Europe approved the first follow-on ... - Lexology (registration)

More clarity for complex biosimilars: Europe approved the first follow-on ... - Lexology (registration) | Immunology and Biotherapies | Scoop.it
More clarity for complex biosimilars: Europe approved the first follow-on ...
Lexology (registration)
The active substance of Remicade is infliximab, a chimeric humane-mouse monoclonal antibody (mAb).
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Australia to adopt EMA’s monoclonal antibody guideline / Guidelines / Home - GaBI online - Generics and Biosimilars Initiative

Australia to adopt EMA’s monoclonal antibody guideline / Guidelines / Home - GaBI online - Generics and Biosimilars Initiative | Immunology and Biotherapies | Scoop.it
Generics and Biosimilars Initiative (Australia to adopt EMA’s monoclonal antibody guideline http://t.co/Gt1Ucd5hyb)
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Frost & Sullivan: Strong Pipeline of Monoclonal Antibodies (mAbs) Biosimilars in the US and Europe Lends Impetus to Global Market

Frost & Sullivan: Strong Pipeline of Monoclonal Antibodies (mAbs) Biosimilars in the US and Europe Lends Impetus to Global Market | Immunology and Biotherapies | Scoop.it
- The market is expected to soar from $1.2 billion of 2013 to $24 billion in 2019 LONDON, Jan. 29, 2014 /PRNewswire/ -- The imminent entry of several companies, including big pharma, small biotech and ...
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Biogen Idec inks pact Samsung Bioepis to market anti-TNF biosimilar products ... - pharmabiz.com

Biogen Idec inks pact Samsung Bioepis to market anti-TNF biosimilar products ... - pharmabiz.com | Immunology and Biotherapies | Scoop.it
Medical Marketing and Media
Biogen Idec inks pact Samsung Bioepis to market anti-TNF biosimilar products ...
Gilbert Faure au nom de l'ASSIM's insight:

for other informations on biosimilars

http://www.scoop.it/t/immunology-and-biotherapies?q=biosimilar

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Biosimilar of Remicade Holds Up at 2 Years

Biosimilar of Remicade Holds Up at 2 Years | Immunology and Biotherapies | Scoop.it
SAN DIEGO -- A monoclonal antibody that's biosimilar” to infliximab (Remicade) in rheumatoid arthritis showed safety and efficacy profiles that were comparable with the now off-patent original biolog (#ACR13 Biosimilar of Remicade Holds Up at 2...
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Physician Groups Side With Big Drug Makers Over Biosimilar Names - Wall Street Journal (blog)

Physician Groups Side With Big Drug Makers Over Biosimilar Names - Wall Street Journal (blog) | Immunology and Biotherapies | Scoop.it
Physician Groups Side With Big Drug Makers Over Biosimilar Names Wall Street Journal (blog) Among the groups that signed the letter: the American Academy of Asthma Allergy and Immunology; the American Academy of Clinical Endocrinologists; the...
Gilbert Faure au nom de l'ASSIM's insight:

The latest missive was sent by 10 medical societies and a physicians’ group, which want the agency to require biosimilars to have distinct names from brand-name biologics. Why? The doctors believe different names will make it easier for prescribers to distinguish between medicines that “may differ slightly” and also track adverse events and side effect reports that appear in patient records.

“The question of whether a follow-on product [or biosimilar] will share a non-proprietary name with a [brand-name biologic] is critical,” the groups wrote yesterday in their letter to FDA Commissioner Margaret Hamburg.

The name game has become a controversial public policy issue. That’s because biosimilars, which are not yet available in the U.S., are designed to emulate brand-name biologics and are forecast to save untold billions of dollars in health care costs in coming years. A key point of contention is whether different names would hamper substitution needed for lowering health care costs.

Brand-name drug makers and biotechs want biosimilars to have unique or generic names to distinguish the medicines, and they cite the same reasons as the medical societies. Of course, a distinct name also gives these companies a marketing advantage. By requiring biosimilars to have different names, product substitution may become more difficult.

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Unambiguous Characterization of N-Glycans of Monoclonal Antibody Cetuximab by Integration of LC-MS/MS and 1H NMR Spectroscopy - Analytical Chemistry (ACS Publications)

Unambiguous Characterization of N-Glycans of Monoclonal Antibody Cetuximab by Integration of LC-MS/MS and 1H NMR Spectroscopy - Analytical Chemistry (ACS Publications) | Immunology and Biotherapies | Scoop.it
Unambiguous Characterization N-Glycans Monoclonal Antibody #Cetuximab LC-MS/MS,1H NMR #mAbs #biosimilar #biosimilars http://t.co/FDDxpWuKKR
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The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD)...

The use of #biosimilars in immune-mediated disease: A joint Italian SIR, SIDeMaST & IG-IBD position paper #biosimilar
http://t.co/koGkoa8jCM
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Biosimilars of etanercept / General / Biosimilars / Home - GaBI online - Generics and Biosimilars Initiative

Biosimilars of etanercept / General / Biosimilars / Home - GaBI online - Generics and Biosimilars Initiative | Immunology and Biotherapies | Scoop.it
Generics and Biosimilars Initiative
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Biosimilars may not deliver cost savings once expected, study finds - BioPharma-Reporter.com

Biosimilars may not deliver cost savings once expected, study finds - BioPharma-Reporter.com | Immunology and Biotherapies | Scoop.it
BioPharma-Reporter.com
Biosimilars may not deliver cost savings once expected, study finds
BioPharma-Reporter.com
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CJSC BIOCAD Announces AcellBia is First mAb Biosimilar Approved by the ... - Business Wire (press release)

CJSC BIOCAD Announces AcellBia is First mAb Biosimilar Approved by the ... - Business Wire (press release) | Immunology and Biotherapies | Scoop.it
CJSC BIOCAD Announces AcellBia is First mAb Biosimilar Approved by the ...
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Herceptin could face biosimilars in UK later this year - PMLiVE

Herceptin could face biosimilars in UK later this year - PMLiVE | Immunology and Biotherapies | Scoop.it
Herceptin could face biosimilars in UK later this year PMLiVE If that occurs the two companies will have two biosimilar monoclonal antibodies on the market in Europe, having secured approval for Inflectra/Remsima, a copycat version of Johnson &...
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BioOutsource Announces Launch Of Flagship Bioassay - BioResearch Online (press release)

BioOutsource Announces Launch Of Flagship Bioassay
BioResearch Online (press release)
Humira and Remicade biosimilars are monoclonal antibodies developed by BioOutsource for the treatment of autoimmune diseases.
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Australia following Europe in evaluation of monoclonal antibody biosimilars | Lexology

Australia following Europe in evaluation of monoclonal antibody biosimilars | Lexology | Immunology and Biotherapies | Scoop.it
Australia's regulatory body for therapeutic goods, the Therapeutic Goods Administration ("TGA"), has initiated public consultations on the adoption… (Australia following Europe in evaluation of monoclonal antibody biosimilars
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Frost & Sullivan: Strong Pipeline of Monoclonal Antibodies (mAbs ...

Frost & Sullivan: Strong Pipeline of Monoclonal Antibodies (mAbs) Biosimilars in the US and Europe Lends Impetus to Global Market. The market is expected to soar from $1.2 billion of 2013 to $24 billion in 2019 ...
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3 Quick Conclusions on a Dropped Biosimilar at Momenta Pharmaceuticals - DailyFinance

3 Quick Conclusions on a Dropped Biosimilar at Momenta Pharmaceuticals - DailyFinance | Immunology and Biotherapies | Scoop.it
3 Quick Conclusions on a Dropped Biosimilar at Momenta Pharmaceuticals DailyFinance On December 19, Baxter International notified Momenta Pharmaceuticals that it was no longer interested in developing M511, a monoclonal antibody biosimilar for...
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this biosimilar will not be developped

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The Approval Of The First Biosimilar Monoclonal Antibody In Europe Has Major ... - PR Newswire (press release)

The Approval Of The First Biosimilar Monoclonal Antibody In Europe Has Major ... - PR Newswire (press release) | Immunology and Biotherapies | Scoop.it
The Approval Of The First Biosimilar Monoclonal Antibody In Europe Has Major ...
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