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Biosimilars Disease Treatment 
ProRelix Research
JULY 6, 2023
Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases.
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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.
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Drug Patent Watch
AUGUST 15, 2023
A recent paper in Expert Opinion on Biological Therapy studies failed fillings for biosimilar drugs.
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Drug Patent Watch
DECEMBER 12, 2024
Consider drugs targeting rare diseases or specialized conditions. Biosimilars and Complex Generics The rise of biosimilars and complex generics is changing the dynamics of market exclusivity. Staying informed about future trends, such as biosimilars and personalized medicine, is crucial for adapting strategies.
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ProRelix Research
MARCH 1, 2024
Biologicals products occupy a significant place in the treatment landscape of several autoimmune diseases and cancers and are most often the only choice of treatment and management of several diseases […] The post Biosimilars and Their Growing Importance in Healthcare appeared first on ProRelix Research.
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ProRelix Research
NOVEMBER 23, 2022
Biological products have unlocked the potential for the management of several diseases such as cancers and autoimmune diseases for which treatment with small molecule, chemically synthesized drug molecules remain suboptimal. […].
The Pharma Data
JUNE 30, 2021
Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG.
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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).
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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.,
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The Pharma Data
MAY 8, 2021
Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Aflibercept is a key treatment in ophthalmology. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. About aflibercept.
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The Pharma Data
APRIL 7, 2022
It may also limit coverage for any future approved treatment in the class. These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas. ADUHELM is indicated for the treatment of Alzheimer’s disease.
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FDA Law Blog: Biosimilars
APRIL 13, 2025
LYTGOBI was granted accelerated approval for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusions or rearrangements. DCR is defined as the sum of complete response (CR), partial response (PR) and stable disease (SD).
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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.
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.
The Pharma Data
MAY 2, 2021
With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.
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The Pharma Data
MAY 31, 2022
BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinson’s disease Phase 2b LUMA to enroll approximately 640 participants with early-stage Parkinson’s disease; most advanced clinical study of a LRRK2 inhibitor. Denali Therapeutics Inc.
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The Pharma Data
MARCH 16, 2022
(Nasdaq: BIIB) announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) today published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease.
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The Pharma Data
MAY 31, 2022
Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Biosimilars match their respective reference medicine in terms of quality, safety and efficacy.
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The Pharma Data
JUNE 2, 2022
BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.
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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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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.
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The Pharma Data
JANUARY 12, 2021
Amgen is a world leader in the treatment of autoimmune disorders, with a portfolio that includes both innovative medicines, including Otezla® and Enbrel®, and biosimilar products, such as AMGEVITA® (a biosimilar to Humira®) and AVSOLA® (a biosimilar to Remicade®). www.evoqtherapeutics.com.
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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 ¶ 57. (The Complaint ¶ 58.
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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 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. About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience.
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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. At Biogen, our mission is clear: we are pioneers in neuroscience.
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The Pharma Data
APRIL 4, 2023
The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. 1 “Living with a chronic disease can take a significant toll on a patient’s quality of life.
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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. At Biogen, our mission is clear: we are pioneers in neuroscience.
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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. About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience.
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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. At Biogen, our mission is clear: we are pioneers in neuroscience.
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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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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. Wednesday, March 10, 2021, 11:00 a.m.
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The Pharma Data
DECEMBER 13, 2020
The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety. SHANGHAI, China, Dec. Both supplemental NDAs received priority review status by the NMPA in July 2020.
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The Pharma Data
NOVEMBER 10, 2020
Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases. On October 31, 2018 , Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
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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.
The Pharma Data
MAY 2, 2022
AUSTEDO is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. On March 9, 2022, the U.S.
The Pharma Data
MARCH 28, 2022
We are incredibly grateful for the selfless commitment of the individuals with ALS who participated in the study, and the community’s dedication to advancing research for this devastating disease,” said Toby Ferguson, M.D., Within each of the six study treatment cohorts, participants were randomized to receive BIIB078 or placebo (3:1 ratio).
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The Pharma Data
DECEMBER 3, 2021
In the zuranolone 50 mg cohort, the majority of patients who responded to an initial 14-day course received only one two-week course of treatment during the study and nearly 80% received only one or two treatment courses in total. of patients discontinuing study drug due to adverse events. 10) and HAMD-17 (? About Zuranolone.
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The Pharma Data
JULY 8, 2021
ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language).
The Pharma Data
NOVEMBER 17, 2021
Tokyo, Japan) blazoned moment an update on the ongoing review of the Marketing Authorization Operation for aducanumab 100 mg/ mL concentrate result for infusion for the treatment of Alzheimer’s complaint by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). and EisaiCo.,Ltd.
The Pharma Data
OCTOBER 18, 2021
About Tofersen Tofersen is an antisense medicine being estimated for the implicit treatment of SOD1-ALS. Tofersen binds to SOD1 mRNA, allowing for its declination by RNase-H in an trouble to reduce conflation of SOD1 protein product.
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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). About Etrasimod. About Ulcerative Colitis.
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The Pharma Data
JUNE 1, 2022
The CGI-S is a clinician-administered 7-point scale that rates the severity of a person’s disease at the time of assessment. . In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. vs. placebo -1.6, p= 0.0052).
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The Pharma Data
AUGUST 1, 2021
Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.
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