Unsuccessful Regulatory Filings for Biosimilar Approval: A Comprehensive Review
Drug Patent Watch
AUGUST 15, 2023
A recent paper in Expert Opinion on Biological Therapy studies failed fillings for biosimilar drugs.
Biosimilars Therapies Treatment 
The Competitive Edge of Biosimilars
DrugBank
SEPTEMBER 26, 2024
Biosimilars Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.
Biosimilars 
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FDA APPROVES RIABNI™ (RITUXIMAB-ARRX), A BIOSIMILAR TO RITUXAN® (RITUXIMAB), FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS?
The Pharma Data
JUNE 7, 2022
New Indication for Amgen’s Fifth FDA-approved Biosimilar. RIABNI is already approved for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (also called Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). In the U.S.,
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AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 654, BIOSIMILAR CANDIDATE TO STELARA® (USTEKINUMAB)
The Pharma Data
APRIL 18, 2022
. “Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines,” said David M. “We look forward to continuing to expand our inflammation portfolio to offer patients a variety of treatment options.” Reese, M.D., million people in the United States.
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Biogen’s Statement on the Final National Coverage Determination for Amyloid-Beta Targeting Therapies for the Treatment of Alzheimer’s Disease
The Pharma Data
APRIL 7, 2022
This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. ADUHELM is indicated for the treatment of Alzheimer’s disease.
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Investment Trends in Pharmaceutical Research
DrugBank
AUGUST 9, 2024
Shorter exclusivity periods, driven by patent challenges and the introduction of generic or biosimilar competitors, significantly contribute to declining ROI. When a drug loses patent protection, generic or biosimilar versions can enter the market, leading to a rapid decline in sales for the original brand-name drug.
Current Clinical Research Trends in GLP-1 (Glucagon-Like Peptide 1) Treatment
Conversations in Drug Development Trends
JULY 9, 2024
The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. However, the treatment journey does not end with weight reduction, as maintaining weight loss overall is equally crucial.
ACR Response Criteria in Rheumatoid Arthritis Clinical Trials
Quanticate
SEPTEMBER 25, 2024
In rheumatoid arthritis (RA) clinical trials, accurately measuring the effectiveness of treatments is critical for determining their value in managing this chronic and debilitating condition.
Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales
FDA Law Blog: Biosimilars
DECEMBER 4, 2023
A prescription not issued in the usual course of professional treatment or in legitimate, authorized research is not a prescription within the meaning of the CSA and the pharmacist knowingly filling it, along with the prescriber issuing it, is subject to penalties. 21 U.S.C. § 829; 21 C.F.R. Complaint ¶ 58. Complaint ¶ 59.
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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability
The Pharma Data
FEBRUARY 25, 2022
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An
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EVOQ Therapeutics Announces a License And Collaboration Agreement with Amgen
The Pharma Data
JANUARY 12, 2021
In exchange for exclusive rights to selected autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million , as well as pay royalties on sales of resulting therapies. EVOQ Therapeutics today announced a license and collaboration agreement with Amgen.
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FDA Action Alert: MacroGenics and Amgen
The Pharma Data
DECEMBER 13, 2020
“We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer.”. About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer.
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New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis
The Pharma Data
OCTOBER 14, 2021
The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.
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The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis
The Pharma Data
NOVEMBER 17, 2021
The blessing of VUMERITY provides a new oral treatment option with low gastrointestinal termination rates that may help cases to start and cleave to treatment,” said Simon Faissner,M.D., In EVOLVE-MS-2, the rate of overall treatment termination was lower in actors treated with VUMERITY compared to those treated with TECFIDERA (1.6
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Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)
The Pharma Data
MAY 2, 2022
The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Sage Therapeutics, Inc.
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Biogen to Participate in SVB Leerink’s 3rd Annual CNS Forum
The Pharma Data
JUNE 25, 2021
Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation.
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BIOGEN TO PARTICIPATE IN THE STIFEL 3RD ANNUAL CNS DAY
The Pharma Data
MARCH 22, 2021
Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation. About Biogen.
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Biogen to Participate in the Morgan Stanley 19th Annual Global.
The Pharma Data
SEPTEMBER 1, 2021
Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation. About Biogen.
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Biogen to Report Second Quarter 2021 Financial Results July 22, 2021
The Pharma Data
JULY 8, 2021
Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Following the live webcast, an archived version of the call will be available on the website.
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BIOGEN TO REPORT FIRST QUARTER 2021 FINANCIAL RESULTS APRIL 22, 2021
The Pharma Data
APRIL 9, 2021
Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Following the live webcast, an archived version of the call will be available on the website. About Biogen.
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Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 Antibody Therapies
The Pharma Data
SEPTEMBER 17, 2020
17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.
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Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation
The Pharma Data
APRIL 4, 2023
Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.
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Biogen and Alectos Therapeutics Announce License and Collaboration Agreement for AL01811, a Novel GBA2 Inhibitor for the Potential Treatment of Parkinson’s Disease
The Pharma Data
JUNE 7, 2022
AL01811 is a preclinical selective GBA2 inhibitor with first-in-class potential as an oral disease modifying treatment for Parkinson’s Disease Alectos to receive a $15 million upfront payment and is eligible to receive potential future development and commercial milestone payments. Biogen Inc.
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Syneos vs Vial | Pros and Cons
Vial
APRIL 24, 2024
In addition to the areas above (aside from DTx), Syneos Health offers biosimilars , cell and gene therapy , endocrine and metabolic, immunology and inflammation, infectious diseases, pediatrics, respiratory, and women’s health services. Dermatology Phase I Units are critical to advancing care and validating treatments.
CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC
The Pharma Data
DECEMBER 13, 2020
On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2 nd line treatment of patients with unresectable or metastatic melanoma. SHANGHAI, China, Dec. Both supplemental NDAs received priority review status by the NMPA in July 2020.
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Denali Therapeutics and Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease
The Pharma Data
MAY 31, 2022
The primary endpoint of LUMA is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III combined score over the treatment period. Denali and Biogen are co-developing and co-commercializing BIIB122 for the potential treatment of Parkinson’s disease.
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BIOGEN TO WEBCAST ADUCANUMAB PRESENTATIONS FROM AD/PD 2021 VIRTUAL CONFERENCE ON MARCH 9-13, 2021
The Pharma Data
MARCH 5, 2021
Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. AD/PD Webcast Schedule Details: Wednesday, March 10, 2021, 6:45 a.m. About Biogen. About Aducanumab.
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A Long Strange Trip: Companion Bills Would Facilitate Psychedelics Research
FDA Law Blog: Biosimilars
APRIL 10, 2023
Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. 21 U.S.C. § Last month bipartisan legislation, S.
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Biogen To Offer Continuity of Care Plan for U.S. Patients Currently Treated with ADUHELM® (aducanumab-avwa)
The Pharma Data
APRIL 28, 2022
currently on ADUHELM avoid any treatment interruptions following the final national coverage determination by Centers for Medicare & Medicaid Services (CMS) that could result in a loss of coverage for Medicare beneficiaries. For those already on ADUHELM, this meant a potential halt in their treatment plans. Organization.
Biogen and Ionis Announce Topline Phase 1 Study Results of Investigational Drug in C9orf72 Amyotrophic Lateral Sclerosis
The Pharma Data
MARCH 28, 2022
While these were not the results we were hoping for, they are clear and will inform future research across our broad pipeline of investigational ALS therapies. We remain focused on pioneering new treatments that will positively impact people living with this debilitating disease.”. Biogen Inc.
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Pfizer Completes Acquisition of Arena Pharmaceuticals
The Pharma Data
MARCH 13, 2022
NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. Pfizer Inc.:
Novartis delivers solid Q3 results, with strong growth in Innovative Medicines. Announces strategic review of Sandoz
The Pharma Data
OCTOBER 26, 2021
Sandoz is a global leader in generic pharmaceuticals and biosimilars. Its global portfolio covers all major therapeutic areas with a global market leadership position in biosimilars, generic antibiotics and oncology medicines. Innovative Medicines net sales were USD 10.6 billion (+8%, +7% cc). percentage points (-3.6
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Teva Announces Settlement with Lupin Resolving AUSTEDO® (deutetrabenazine) Patent Dispute
The Pharma Data
MAY 2, 2022
Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. AUSTEDO (deutetrabenazine) tablets is indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.
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First Participant Dosed in Pfizer’s Pivotal Phase 3 TALAPRO-3 Combination Study of Talazoparib and Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
The Pharma Data
JUNE 24, 2021
The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,
Combination of copanlisib and rituximab significantly increases progression-free survival in patients with relapsed indolent non-Hodgkin’s Lymphoma
The Pharma Data
APRIL 11, 2021
under the accelerated approval pathway for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. The CHRONOS-3 data signals a much-needed advancement in the iNHL treatment paradigm,” said Pier Luigi Zinzani, M.D., Abstract: CT001. About CHRONOS-3.
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Pfizer Announces Positive Top-Line Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients
The Pharma Data
MARCH 23, 2022
(NYSE: PFE) today announced positive topline results from a Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). Participants received etrasimod 2mg once daily.
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ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease
The Pharma Data
MARCH 16, 2022
Food and Drug Administration (FDA) granted accelerated approval for ADUHELM as the first Alzheimer’s disease treatment to address a defining pathology of the disease. ADUHELM is indicated for the treatment of Alzheimer’s disease. SVP, Head of Neurodegeneration Development at Biogen. “We
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Sage Therapeutics and Biogen Announce that the Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression Met its Primary and All Key Secondary Endpoints
The Pharma Data
JUNE 1, 2022
In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. About Zuranolone Zuranolone (SAGE-217/BIIB125) is a once-daily, two-week, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
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ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease in Patients Treated for More Than Two Years
The Pharma Data
MARCH 16, 2022
These findings point to the potential of continued benefit of treatment in the longer term with continued reduction of amyloid beta plaques. These data demonstrate that long-term treatment with ADUHELM continues to reduce the underlying pathologies of Alzheimer’s disease beyond two years.” Biogen Inc. About Biogen.
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Collaboration between AbbVie, Biogen and Pfizer creates world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease
The Pharma Data
JULY 15, 2021
Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.
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Molecular Partners Announces Collaboration With Novartis to Develop Two DARPin(R) Therapies Designed for Potential Use Against COVID-19
The Pharma Data
OCTOBER 27, 2020
MP0420 and MP0423 are potential medicines with a unique approach for both the prevention and treatment of COVID-19, with the possibility to manufacture at scale, easy administration and with the potential to bypass cold storage. These factors provide the possibility of developing and manufacturing this innovation at scale.
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Pfizer Announces Positive Top-line Results from Yearlong Phase 3 Trial of Etrasimod in Ulcerative Colitis, Underscoring Best-in-Class Potential
The Pharma Data
MARCH 29, 2022
(NYSE: PFE) today announced positive top-line results from a second Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). Participants received etrasimod 2 mg or placebo once-daily.
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Pfizer to Present Latest Scientific Advancements from Its Industry-Leading Portfolio at the ESMO Virtual Congress 2020
The Pharma Data
SEPTEMBER 10, 2020
(NYSE:PFE) announced today that more than 50 abstracts representing data from nine approved and investigational Pfizer medicines, including several biomarker-driven and immuno-therapies, will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 being held from September 19-21, 2020. Solomon B. . .
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Amgen Reports Second Quarter 2021 Financial Results
The Pharma Data
AUGUST 3, 2021
Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.
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