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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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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.
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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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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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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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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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.
DrugBank
AUGUST 9, 2024
Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. Shorter exclusivity periods, driven by patent challenges and the introduction of generic or biosimilar competitors, significantly contribute to declining ROI.
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
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.”. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.
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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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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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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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Vial
APRIL 24, 2024
Introduction In a landscape where many contract research organizations (CROs) are available, Vial is breaking through with its promise to deliver on its vision to empower scientists to cure all human diseases by reimagining clinical trials. Oncology Despite significant progress in cancer research, many patients face limited treatment options.
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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Drug Target Review
JULY 6, 2023
1 Ethical concerns surrounding the use of animal studies is increasing, especially considering 90 percent of drug candidates fail in clinical trials. 2 Therefore, the scientific community is researching and developing efficient ways to test compounds without the use of animals, to avoid unsuccessful outcomes in clinical trials.
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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
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
JUNE 24, 2021
today announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The TALAPRO-3 trial will enroll approximately 550 men with DDR-deficient mCSPC across 285 clinical trial sites in 28 countries. About TALAPRO-3 Trial.
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
APRIL 11, 2021
This data will be presented in a Clinical Trials Plenary Session on April 10 at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 and simultaneously published in The Lancet Oncology. The CHRONOS-3 data signals a much-needed advancement in the iNHL treatment paradigm,” said Pier Luigi Zinzani, M.D.,
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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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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
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. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents.
Agency IQ
JANUARY 19, 2024
Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.
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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.
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The Pharma Data
SEPTEMBER 10, 2020
“Meaningful innovation in cancer care requires building upon our understanding of tumor biology, leveraging cutting-edge research, and applying the knowledge we gain into new treatments that address and prevent resistance,” said Chris Boshoff, M.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We Solomon B. . .
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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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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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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.
The Pharma Data
FEBRUARY 8, 2021
IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S.,
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