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Biosimilars Treatment Trials 
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
DECEMBER 10, 2024
Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies. Another significant challenge is the high cost of development.
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Drug Patent Watch
DECEMBER 12, 2024
Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. Drugs that require extensive clinical trials for generic approval or fall under special regulatory pathways may have a lower risk of generic entry.
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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 post Biosimilar Clinical Trials and US FDA Guidance appeared first on ProRelix Research.
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.
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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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. As a single-arm trial (i.e., Join us as we break down what went wrong this time. What Happened?
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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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FDA Law Blog: Biosimilars
SEPTEMBER 15, 2024
IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Eliminating invalid patents under § 101 enables generic and biosimilar companies to streamline pharmaceutical litigation.
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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
APRIL 7, 2022
It may also limit coverage for any future approved treatment in the class. When additional data from this new class of treatments become available, Biogen urges CMS to reconsider today’s decision for all FDA-approved amyloid-beta targeting therapies. ADUHELM is indicated for the treatment of Alzheimer’s disease.
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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
JULY 8, 2021
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). ADUHELM is indicated for the treatment of Alzheimer’s disease. ADUHELM is indicated for the treatment of Alzheimer’s disease.
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). The safety profile was consistent with previous Phase 2 studies.
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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
NOVEMBER 10, 2020
that are fast progressing clinical trials. 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. SAN FRANCISCO and SUZHOU, China , Nov.
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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. In June 2021, the U.S.
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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
NOVEMBER 9, 2020
Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.
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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. The world’s first-in-human, first-in-class BTLA blocking antibody for solid tumors is currently in phase I clinical trials in the US and China. SHANGHAI, China, Dec.
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The Pharma Data
MARCH 16, 2022
The data also show that in both Phase 3 trials, at 78 weeks, patients with reduced levels of plasma p-tau181 had less clinical decline than those whose plasma p-tau181 levels were not reduced. These findings point to the potential of continued benefit of treatment in the longer term with continued reduction of amyloid beta plaques.
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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
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. billion) and Entresto (at least USD 5.0 Innovative Medicines net sales were USD 10.6 billion (+8%, +7% cc).
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The Pharma Data
DECEMBER 21, 2020
21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,
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FDA Law Blog: Biosimilars
JULY 10, 2024
Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.
The Pharma Data
JANUARY 24, 2021
Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma.
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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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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. Zuranolone is being estimated in the Geography and NEST clinical trial programs. 10) and HAMD-17 (?
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FDA Law Blog: Biosimilars
SEPTEMBER 26, 2024
In particular, CDRH touts its Breakthrough Devices Program, which it advertises as a “program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
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The Pharma Data
MAY 2, 2022
Patent Office Patent Trial and Appeal Board declined to institute an Inter Partes Review of Teva’s compound patent for deutetrabenazine in response to a petition submitted by Apotex. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.
The Pharma Data
MARCH 28, 2022
We remain focused on pioneering new treatments that will positively impact people living with this debilitating disease.”. This Phase 1 study was a randomized, placebo-controlled, dose-escalating trial to evaluate BIIB078 administered intrathecally to adults (n=106) with C9orf72-associated ALS.
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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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FDA Law Blog: Biosimilars
SEPTEMBER 17, 2024
UBRELVY is indicated for the acute treatment of migraine with or without aura in adults and is not indicated for the preventive treatment of migraine. Advantage, OPDP. Specifically, OPDP alleges the ad implies that UBRELVY quickly eliminates migraine pain after just one dose, which was not fully supported by clinical data.
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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Agency IQ
AUGUST 2, 2024
Title Type Date Received by OIRA Legal Deadline Expedited Program for Serious Conditions –Accelerated Approval of Drugs and Biologics Draft Guidance July 9 Yes Conducting Clinical Trials With Decentralized Elements Draft Guidance July 25 Yes Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Draft (..)
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Agency IQ
JUNE 9, 2023
Commission Regulation (EC) No 847/2000 set the rules, defining an orphan drug as one “that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made.” no available treatment.
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The Pharma Data
SEPTEMBER 16, 2020
About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in early 2021.
The Pharma Data
JULY 27, 2021
” The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. chief executive officer of Teneobio. ” In June 2021, AbbVie Inc.
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The Pharma Data
SEPTEMBER 20, 2020
No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). Eleven (18.6%) patients had grade 3 or higher TRAEs, one of whom had grade 3 TRAEs of ALT and AST increases that led to discontinuation of treatment. The Phase 2 CRC trial is expected to have a data readout in 2021.
FDA Law Blog: Biosimilars
AUGUST 11, 2024
AUVI-Q is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects… biting insects… allergen immunotherapy, foods, drugs, diagnostic testing substances… and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
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Agency IQ
MAY 3, 2024
Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.
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FDA Law Blog: Biosimilars
JUNE 21, 2023
As acknowledged in the Strategic Priorities document, certain demographic groups may have limited access to necessary treatments and diagnostics. What are ways that digital health technologies can (a) foster the conduct of clinical trials remotely and (b) support local or home-based healthcare models?
The Pharma Data
DECEMBER 27, 2020
This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.
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