Biosimilars Newsfeed
First Trastuzumab Biosimilar, Ogivri, Approved by FDA
(FDA News Release, December 1, 2017)
Nearly Half of U.S. Physicians Say They Will Prescribe More Biosimilars, According to New Data From InCrowd
Marketwired (03/03/16)
Clinical and Regulatory Perspectives on Biosimilar Therapies and Intended Copies of Biologics in Rheumatology
Rheumatology International (02/27/2016) Mysler, E.; Pineda, C.; Horiuchi, T.
Biosimilars in the Management of Neutropenia: Focus on Filgrastim
Biologics: Targets and Therapy (02/18/2016) Vol. 10, P. 17; Caselli, D.; Cesaro, S.; Aricò, M.
Biosimilars in Development Near End of Phase 3 Trials
Managed Care (02/01/16) Adams, Katherine T.
Evaluation of Immunogenicity of LY2963016 Insulin Glargine Compared With Lantus Insulin Glargine in Patients With Type 1 or Type 2 Diabetes Mellitus
Diabetes, Obesity, and Metabolism (02/01/2016) Vol. 18, No. 2, P. 159; Ilag, LL; Deeg, MA; Costigan, T
Development, Safety, and Efficacy of Biosimilar Adalimumab: The Data So Far
Biosimilars (01/29/2016) Vol. 06, P. 01; Gabbani, Tommaso; Deiana, Simona; Bagnoli, Siro
Current Status of Biosimilars in the Treatment of Inflammatory Bowel Diseases
Intestinal Research (01/26/2016) Park, D.I.
Biosimilar Therapies in Inflammatory Bowel Disease: Should We Care About Patient Profile?
Expert Review of Clinical Immunology (02/16) Fiorino, Gionata; Fazio, Maria; Danese, Silvio
Amgen's Humira Biosimilar Accepted for FDA Review
Bloomberg BNA (01/26/16) Aquino, John T.
What Happened in Biosimilars During 2015
Generics and Biosimilars Initiative (GaBI) (01/22/2016)
Biosimilar Issues on the FDA Guidance Agenda for 2016
U.S. Food and Drug Administration (01/22/2016)
Comparable Long-Term Efficacy, as Assessed by Patient-Reported Outcomes, Safety and Pharmacokinetics, of CT- P13 and Reference Infliximab
Arthritis Research & Therapy (01/20/2016) Vol. 18, No. 1, P. 25; Park, W.; Yoo, D.H.; Jaworski J.
Benepali, the First Etanercept Biosimilar Referencing Enbrel, Approved in the European Union
Business Wire (01/16/16)
Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices
BioDrugs (01/13/2016) Vol. 30, No. 1, P. 1; Ebbers, H.C.; Chamberlain, Paul
Phase III Data Shows Sandoz Proposed Biosimilar Pegfilgrastim Has Similar Safety and Efficacy as the Reference Product
NASDAQ (12/17/15)
Core Concepts: Biosimilars
Proceedings of the National Academy of Sciences (12/15/15) Vol. 112, No. 50, P. 15261; Ornes, Stephen
Implementation of the Biosimilars Provisions of the ACA — Where Are We Now?
Health Affairs Blog (12/14/15) Wynne, Billy
Stakeholders Say Biosimilars Names Should Be Meaningful and Memorable
Mondaq (12/02/15) Royzman, Irena; Siegel, Jacob F.
The Evolving Role of Biosimilars in Haematology-Oncology: A Practical Perspective
Therapeutic Advances in Hematology (12/01/2015) Vol. 6, No. 6, P. 267; Gascon, P.
EU Endorses Copy of Enbrel Arthritis Drug From Samsung, Biogen
Economic Times (India) (11/21/15)
Biosimilars in the United States: Considerations for Oncology Advanced Practitioners
Journal of the Advanced Practitioner in Oncology (04/01/2015) Vol. 6, No. 2, P. 108; Mayden, K.D.; Larson, P.; Geiger, D.
In Response to a Request for Comments on Its Guidance for Industry on the 'Nonproprietary Naming of Biological Products'
Federal Trade Commission (10/27/15)
Samsung Bioepis' SB4 and SB2 Investigational Biosimilar Candidates Sustain Comparable Safety Profiles in One-Year Phase 3 Clinical Studies
PipelineReview.com (11/07/15)
Boehringer Ingelheim's Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab
Business Wire (10/28/2015)
Boehringer Ingelheim Announces Completed Enrollment of Phase III Clinical Trial for Biosimilar Candidate to Adalimumab
Business Wire (11/10/2015)
Amgen Presents Detailed Results From Phase 3 Study Demonstrating Clinical Equivalence Of Biosimilar Candidate ABP 501 With Adalimumab
PipelineReview.com (11/10/15)
FDA Rejects Hospira's EPO Biosimilar Application
Lexology (11/05/15) Cohen, Andrew D.; Royzman, Irena
CMS Payment Provisions Part B Drugs/Payment for Biosimilar Biological Products
CMS.gov (10/30/2015)
Update on Biosimilars of Granulocyte Colony-Stimulating Factor – When No News Is Good News
Current Opinion in Hematology (11/07/2015) Schulz, M.; Bonig, H.
ASBM Releases Pharmacist Survey; Findings Show Strong Support for Distinguishable Names for Biologics and Need for Transparency in Labeling
PR Newswire (10/13/15)
Evaluation of Biosimilars for Formulary Inclusion: Factors for Consideration by P&T Committees
P&T Community (10/01/15) Vol. 40, No. 10, P. 680; Ventola, C. Lee
Biosimilars in Immune-Mediated Inflammatory Diseases
Journal of Internal Medicine (09/15) Isaacs, J.D.; Cutolo, M.; Keystone, E.C.
Pharmacovigilance Considerations for Biosimilars in the USA
BioDrugs (09/29/2015) Grampp, G.; Felix, T.
Biosimilars--Terms of Use
Current Medical Research and Opinion (10/15) Declerck, P.; Mellstedt, H.; Danese, S.
Challenges in the Implementation of Trastuzumab Biosimilars: An Expert Panel's Recommendations
Anticancer Drugs (11/01/2015) Vol. 26, No. 10, P. 1009; Pivot, X.; Aulagner, G.; Blay, J.Y.
FDA Accepts Sandoz Regulatory Submission for a Proposed Biosimilar Etanercept
MarketWatch (10/02/15)
Biosimilar Monoclonal Antibodies: The Scientific Basis for Extrapolation
Expert Opinion on Biological Therapy (09/15) P. 1; Schellekens, H.; Lietzan, E.; Faccin, F.
Key Strategic Factors for Stakeholders in the Current Global Biosimilar Market
Drug Discovery Today (09/15) Casey, D.
Biosimilarity Versus Manufacturing Change: Two Distinct Concepts
Pharmaceutical Research (09/17/2015) Declerck, P.; Farouk-Rezk, M.; Rudd, P.M.
The Immunogenicity of Biosimilar Infliximab: Can We Extrapolate the Data Across Indications?
Expert Review of Gastroenterology & Hepatology (09/22/2015) Ben-Horin, Shomron; Heap, Graham A.; Ahmad, Tariq
Clinical Efficacy and Safety of Biosimilar Epoetin: Focus on Epoetin Zeta
Biosimilars (09/09/2015) Vol. 2015, No. 5, P. 65; Mikhail, Ashraf; Brown, Christopher
Senators Tell FDA to Pick up the Pace on Biosimilar Guidelines
Modern Healthcare (09/17/15) Johnson, Steven Ross
Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability
Federal Register (08/28/15)
Pharmacist Substitution of Biological Products: Issues and Considerations
Journal of Managed Care & Specialty Pharmacy (07/01/15) Vol. 21, No. 7, P. 532; Li, E.; Ramanan, S.; Green, L.
Competition in the Age of Biosimilars
Journal of the American Medical Association (07/21/15) Vol. 314, No. 3, P. 225; Chandra, Amitabh; Vanderpuye-Orgle, Jacqueline
Biosimilars in Rheumatology: Current Perspectives and Lessons Learnt
Nature Reviews Rheumatology (08/18/2015) Dörner, T.; Kay, J.
Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update
Journal of Clinical Oncology (07/15) Smith, Thomas J.; Bohlke, Kari; Lyman, Gary H.
AGA Survey Reveals Respondents' Views on Biosimilar Drugs
American Gastroenterological Association (07/30/15)
Comparison of EP2006, a Filgrastim Biosimilar, to the Reference
Annals of Oncology (09/01/2015) Blackwell, K.; Semiglazov, V.; Krasnozhon, D.
State-of-the-Art Biosimilar Erythropoietins in the Management of Renal Anemia
International Urology and Nephrology (09/01/2015) Vol. 47, No. 9, P. 1529; Covic, A.; Abraham, I.
New Quantia Report Reveals Physician Attitudes Toward Biosimilars
Business Wire (08/18/15)
Biosimilars Forum Expresses Concern With CMS Proposed Rule on Biosimilar Payment and Coding
Biosimilars Forum (07/09/15)
Biosimilars in Inflammatory Bowel Disease: Ready for Prime Time?
Current Opinion in Gastroenterology (07/01/2015) Vol. 31, No. 4, P. 290; Gomollón, F.
IBD: Indication Extrapolation for Anti-TNF Biosimilars
Nature Reviews Gastroenterology & Hepatology (06/16/2015) Casteele, Niels Vande; Sandborn, William J.
Debate Over Naming of Biosimilars Intensifies Ahead of WHO Meeting
Pharmaceutical Journal (06/11/15) Murphy, Bernard
Biosimilar Safety Factors in Clinical Practice
Seminars in Arthritis & Rheumatism (06/01/2015) Vol. 44, Reinisch, W.; Smolen, J.
Establishing a New Marketplace for Biologic Therapy With Biosimilar Agents: Importance of Extrapolation of Data
Biosimilars (06/01/2015) Vol. 5, P. 41; Bressler, Brian; Dingermann, Theo
Biosimilars: What Do Patients Need to Consider?
European League Against Rheumatism (EULAR) (04/01/2015) Skingle, Diana
WHO Receives Positive Feedback on BQ for Biologicals
Generics and Biosimilars Initiative (GaBI) (04/27/2015)
Biosimilars: New Guidance From FDA to Help Manufacturers Develop More Treatment Options
FDA Voice blog (05/14/15) Christl, Leah
New Forum Launches to Expand Access to Biosimilar Medicines, Improve Healthcare
Biosimilars Forum (05/05/15)
Progress and Hurdles for Follow-on Biologics
New England Journal of Medicine (05/06/15) Sarpatwari, Ameet; Avorn, Jerry; Kesselheim, Aaron S.
Physician Groups Urge FDA to Ensure Patient Safety with Greater Transparency in Biosimilar Labeling
Biosimilar News (05/22/2015)
Inflammatory Diseases: Integrating Biosimilars Into Clinical Practice
Seminars in Arthritis & Rheumatism (04/08/2015) Feldman, Steven R.
Clinical Trials for Etanercept Biosimilars
Generics and Biosimilars Initiative (GaBI) (05/22/2015)
CMS Issues Guidance on Biosimilar Reimbursement and Formulary Policy
American Society of Hematology (04/09/2015)
CMS Biosimilar Part B and Part D Guidance
Centers for Medicare & Medicaid Services (03/30/15)
Amgen Loses Bid to Block a Biosimilar Version of Its Best-Selling Drug
Wall Street Journal (03/20/15) Silverman, Ed
Clinical Data Shows Proposed Biosimilar, Epoetin Hospira, Demonstrates Pharmacokinetic and Pharmacodynamic Equivalence to Amgen's Epogen
PR Newswire (03/27/15)
Comparability of Biosimilar Filgrastim with Originator Filgrastim: Protein Characterization, Pharmacodynamics, and Pharmacokinetics
BioDrugs (04/03/2015) Sörgel, F.; Schwebig, A.; Holzmann, J.
European Group Criticizes Proposed WHO, FDA Biosimilar Naming Schemes
BioPharma-Reporter.com (04/13/2015) Brennan, Zachary
Biosimilar Approval Brings New Awareness Levels for Community Pharmacists
Pharmacy Times (04/15/15) Oldfield, Eileen
Biosimilar: What It Is Not
British Journal of Clinical Pharmacology (04/11/15) de Mora, Fernand
Considerations in the Early Development of Biosimilar Products
Drug Discovery Today (01/06/2015) Li, E.C.; Abbas, R.; Jacobs, I.A.
The Emerging Role of Biosimilar Epoetins in Nephrology in the United States
American Journal of Kidney Diseases (04/15) Vol. 65, No. 4, P. 537; Fishbane, S.; Shah, H.H.
Biosimilar Competition in the United States: Statutory Incentives, Payers, and Pharmacy Benefit Managers
Health Affairs (Quarter 1, 2015) Vol. 34, No. 2, P. 294; Falit, Benjamin P.; Singh, Surya C.; Brennan, Troyen A.
New ASBM Survey Provides Physicians' Views on Biosimilar Labeling
Alliance for Safe Biologic Medicines (03/23/2015)
Assessment of Pharmacists' Views on Biosimilar Naming Conventions
Journal of Managed Care & Specialty Pharmacy (03/01/15) Vol. 21, No. 3, P. 188; Fernandez-Lopez, Sara; Kazzaz, Denise; Bashir, Mohamed
Clinical Considerations for the Development of Biosimilars in Oncology
mAbs (03/01/2015) Vol. 07, No. 2, P. 286; Socinskia, Mark A.; Curigliano, Giuseppe; Jacobs, Ira
Biosimilars: The Science of Extrapolation
Blood (11/20/14) Vol. 124, No. 22, P. 3191; Weise, M.; Kurki, P.; Wolff-Holz, E.
American College of Rheumatology Position Statement: Biosimilars
American College of Rheumatology (02/01/15)
