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USP Publishes Monoclonal Antibody Guidelines

USP Publishes Monoclonal Antibody Guidelines | Immunology and Biotherapies | Scoop.it
As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable that the role of biologics has rapidly expanded in healthcare, raising questions and presenting crucial issues associated with their quality and efficacy. Unlike small-molecule medicines, which have more easily defined quality attributes and are relatively easy to characterize, biologics are large-molecule drugs, typically manufactured using living cells. Because biologic medicines range from simple structures like certain peptides to complex mixtures, such as vaccines, establishing meaningful quality attributes for each specific product can present challenges.

Besides serving a much reduced patient population because of their specific applications, biologics manufacturing requires living material and a much more complicated process than small-molecule synthesis, making a biologic drug naturally more costly. 

USP standards for mAbs
Currently, licensed monoclonal antibody (mAb) therapeutics include those involved in the activation of effector cells, cell killing, cross-linked induced apoptosis, antagonism against several targets, and agonist antibodies. Because of structural similarities between antibodies of the same class, the United States Pharmacopeial Convention’s (USP) expert panel decided to focus its efforts in developing standards for mAbs on a class of molecules that would be more amenable to a “platform approach” both in terms of manufacturing and analytical development. 

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Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases, Immunotherapy, Future Medicine

Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases, Immunotherapy, Future Medicine | Immunology and Biotherapies | Scoop.it
Progress in #biosimilar monoclonal antibody development: the #infliximab biosimilar CT-P13 in rheumatic diseases http://t.co/fwka4qpg6i
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FDA Announces an Advisory Committee Meeting Regarding the First Monoclonal Antibody Biosimilar Application

FDA Announces an Advisory Committee Meeting Regarding the First Monoclonal Antibody Biosimilar Application | Immunology and Biotherapies | Scoop.it
The FDA has announced a public advisory committee meeting to discuss a
biologics license application for a proposed biosimilar to Janseen Biotech
Inc.’s Remicade submitted by Celltrion, Inc.
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Celltrion Healthcare: Data show the world’s first EMA-approved biosimilar monoclonal antibody Remsima™ could reduce cost of treating Crohn’s disease by up to €336 million over five ye...

Celltrion Healthcare: Data show the world’s first EMA-approved        biosimilar monoclonal antibody Remsima™ could reduce cost of treating        Crohn’s disease by up to €336 million over five ye... | Immunology and Biotherapies | Scoop.it
INFH UXEYX 200215010158. http://t.co/dT9ozhiIil
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Hospira launches first biosimilar monoclonal antibody Inflectra (infliximab) in major European markets | Today Topics

Hospira, Inc., a world leader in the development of biosimilar therapies, has announced the launch of the first biosimilar monoclonal antibody (mAb), Inflectra
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EMA accepts Enbrel biosimilar application for review - Healio

EMA accepts Enbrel biosimilar application for review - Healio | Immunology and Biotherapies | Scoop.it
Rheumatology | The European Medicines Agency has accepted a biosimilar Enbrel candidate from Samsung Bioepis of South Korea, according to a company press release.In Europe and the U.S., Enbrel (etanercept, Amgen) is indicated for the treatment of...
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Epirus and Ranbaxy launch a Remicade biosimilar in India - FiercePharma

Epirus and Ranbaxy launch a Remicade biosimilar in India - FiercePharma | Immunology and Biotherapies | Scoop.it
The biosimilar bonanza is underway, and Johnson & Johnson's rheumatoid arthritis drug Remicade is at the center of the copycat action.
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Useful insights: Europe slow to embrace biosimilars of antibody-based drugs - BioPharma Dive

Useful insights: Europe slow to embrace biosimilars of antibody-based drugs - BioPharma Dive | Immunology and Biotherapies | Scoop.it
After the EMA approved Hospira's Inflectra—a biosimilar of J&J's Remicade (infliximab)—Hospira launched an intensive marketing campaign. Here's an overview of what's happened since then.
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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...
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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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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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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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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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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 ...
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for other informations on biosimilars

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

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Revenues for Biosimilar Monoclonal Antibody Therapies Will Exceed $4BN | ASDReports

Revenues for Biosimilar Monoclonal Antibody Therapies Will Exceed $4BN | ASDReports | Immunology and Biotherapies | Scoop.it
A new report, now available on ASDReports, forecasts the overall world market for biosimilar monoclonal antibodies (mAbs) will exceed $4bn by 2020. Th
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Celltrion launches world’s first biosimilar monoclonal antibody Remsima™ in 12 new European markets | Feel on

Celltrion launches world’s first biosimilar monoclonal antibody Remsima™ in 12 new European markets | Feel on | Immunology and Biotherapies | Scoop.it
INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare has today announced the launch of Remsima™ (infliximab) in 12 European markets: Austria,
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Oncobiologics - Understanding Biosimilars Development

Oncobiologics - Understanding Biosimilars Development | Immunology and Biotherapies | Scoop.it

The development of complex biosimilars, such as monocolonal antibodies and fusion proteins, is an exceptionally challenging technical undertaking.  Unlike traditional small molecule pharmaceuticals which are essentially formula driven chemicals, complex biologics are much larger, multifaceted molecules.  To illustrate the relative levels of complexity, a traditional aspirin molecule can be likened to a bicycle, while a simple biologics (such as human growth hormone) can be likened to an automobile.  A complex biologic, such as a monoclonal antibody (mAb), meanwhile, is analogous to a modern commercial airliner.

 

Due to the complexity of mAb’s and fusion proteins, the requirements for establishing that a biosimilar molecule is biologically comparable to the original innovator molecule require comprehensive and exquisite science. The BioSymphony model for biosimilars development was specifically designed to address those scientific and regulatory requirements, within a framework of rapid, low-cost, high quality execution, as illustrated below.

 

  

© 2015 Oncobiologics, Inc.

 

 


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from small to big...

and specificity is different

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Krishan Maggon 's curator insight, February 21, 10:26 AM
BIOSIMILARS PRODUCT PIPELINE

BIOSIMILAR ASSETS

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Hospira launches first biosimilar monoclonal antibody Inflectra (infliximab) in major European markets

Hospira launches first biosimilar monoclonal antibody Inflectra (infliximab) in major European markets | Immunology and Biotherapies | Scoop.it
Hospira, Inc., announced the launch of the first biosimilar monoclonal antibody, Inflectra (infliximab), in major European markets. Inflectra is licensed for
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Hospira's Remicade copycat up for FDA review as US biosimilars March on - BioPharma-Reporter.com

Hospira's Remicade copycat up for FDA review as US biosimilars March on - BioPharma-Reporter.com | Immunology and Biotherapies | Scoop.it
The US FDA has set a date to review its first monoclonal antibody (mAb) biosimilar: a version of J&J’s Remicade marketed by Pfizer takeover target Hospira.
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Physicochemical characterization of Remsima®

Physicochemical characterization of Remsima® | Immunology and Biotherapies | Scoop.it
(2014). Physicochemical characterization of Remsima®. mAbs: Vol. 6, No. 5, pp. 1163-1177. doi: 10.4161/mabs.32221

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first biosimilar

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Krishan Maggon 's curator insight, December 19, 2014 6:43 AM
mAbsVolume 6, Issue 5, 2014 Physicochemical characterization of Remsima® View full textDownload full textOpen accessDOI:10.4161/mabs.32221Soon Kwan Junga, Kyoung Hoon Leea, Jae Won Jeona, Joon Won Leea, Byoung Oh Kwona, Yeon Jung Kima, Jin Soo Baea, Dong-Il Kimb, Soo Young Leea & Shin Jae Changa*

pages 1163-1177

Publishing models and article dates explainedReceived: 30 Jun 2014Accepted: 30 Jul 2014Accepted author version posted online: 01 Nov 2014
Published online: 01 Sep 2014Article Views: 1197  http://www.celltrionhealthcare.com/remsima/com/
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Celltrion Healthcare Presents Clinical Data Showing That Inflammatory Bowel Disease Patients Should Be Treated With Biosimilar Monoclonal Antibody (mAb) Infliximab

Celltrion Healthcare Presents Clinical Data Showing That Inflammatory Bowel Disease Patients Should Be Treated With Biosimilar Monoclonal Antibody (mAb) Infliximab | Immunology and Biotherapies | Scoop.it
Read About Celltrion Healthcare Presentatio About Their Clinical Experience Showing That Inflammatory Bowel Disease Patients Should Both Be Treated With Biosimilar Monoclonal Antibody (mAb) Infliximab.
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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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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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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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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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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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