Biosimilar

Samsung Bioepis to Present Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congress 2024

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木曜日, 5月 30, 2024
PNH, Patient, Pharmacokinetics, Anemia, Hope, Biosimilar, ECU, Trial of the century, Safety, Chelsea Handler, LDH, Eculizumab, European Commission, Hemolysis, Medicine, RBC, Pivotal, Pharmaceutical industry

INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that a post-hoc analysis of the Phase 3 clinical study results for EPYSQLI™ (SB12), a biosimilar to Soliris1 (eculizumab), will be presented at the 29th European Hematology Association 2024 (EHA2024) Hybrid Congress held in Madrid, Spain and virtually, from June 13 to 16, 2024.

Key Points: 
  • INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that a post-hoc analysis of the Phase 3 clinical study results for EPYSQLI™ (SB12), a biosimilar to Soliris1 (eculizumab), will be presented at the 29th European Hematology Association 2024 (EHA2024) Hybrid Congress held in Madrid, Spain and virtually, from June 13 to 16, 2024.
  • SB12 has shown equivalent efficacy with reference eculizumab (ECU) by lactate dehydrogenase (LDH) and comparable safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles in paroxysmal nocturnal hemoglobinuria (PNH) through the pivotal Phase 3 study.2
    The post-hoc analysis of SB12 pivotal Phase 3 study presented at EHA2024 compared the proportion of patients remaining transfusion-free (“transfusion avoidance”) among those treated with SB12 or ECU, respectively.
  • Eculizumab is known to significantly reduce hemolysis resulting in improvements in anemia as indicated by increased hemoglobin stabilization and reduced need for red blood cell (RBC) transfusions.3
    “We are excited to present this data at EHA2024, that adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients,” said Hyejin Kim, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis.
  • In March 2024, EPYSQLI was granted an indication expansion for the treatment of adults and children with atypical haemolytic uremic syndrome (aHUS).4

Samsung Bioepis Announces Oral Presentation on Switching Period Results for SB16, a Proposed Biosimilar to Prolia (Denosumab) at the European Calcified Tissue Society (ECTS) Congress 2024

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月曜日, 5月 27, 2024
Randomness, Denosumab, Pharmacokinetics, SB16, PD, Month, LSM, Safety, Comparison, DEN, Congress, BMD, Osteoporosis, ECTS, Society, Biosimilar, Annual general meeting, Vaccine

At Month 12, patients were re-randomized into switching period to continue their treatment (SB16+SB16, or DEN+DEN) or switch from DEN to SB16 (DEN+SB16).

Key Points: 
  • At Month 12, patients were re-randomized into switching period to continue their treatment (SB16+SB16, or DEN+DEN) or switch from DEN to SB16 (DEN+SB16).
  • The mean percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 18 was comparable between treatment groups.
  • The mean % change from baseline in total hip BMD and femoral neck BMD at Month 18 were comparable between treatment groups.
  • Details of the SB16 abstract presented at ECTS 2024 are as follows:
    A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis: 18-Month Results

Dr. Reddy's Laboratories Announces the Appointment of Milan Kalawadia to CEO North America

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火曜日, 5月 28, 2024
Pharmaceutical, Science, Health, Research, Business school, Rx, Business administration, Biosimilar, Wellness, Marketing, Rutgers University, Tepper School of Business, NAG, Growth, RDY, OTC, Carnegie Mellon University, Acquisition, School, SRX, Information system, Laboratory, Multimedia

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced the appointment of Milan Kalawadia as Chief Executive Officer, North America, and member of the Management Council.

Key Points: 
  • Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced the appointment of Milan Kalawadia as Chief Executive Officer, North America, and member of the Management Council.
  • As part of the Dr. Reddy’s senior leadership team, he will be responsible for the company’s North America business and will be based out of the Princeton, New Jersey, U.S. office.
  • View the full release here: https://www.businesswire.com/news/home/20240528120424/en/
    “I am excited to start this next chapter in my journey at Dr. Reddy’s,” says Milan Kalawadia.
  • Milan led the early efforts to develop strategies for the Biosimilars and the Self-care & Wellness business units in the US.

Alvotech Reports Financial Results for First Quarter of 2024 and Provides a Business Update

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火曜日, 5月 21, 2024
Partnership, CTA, Patient, EBIDTA, Icelandic, Food, Movement, Clinical trial, FDA, EDT, Marketing, Ustekinumab, Food and Drug Administration, Absorption, Denosumab, Research, G&A, Biosimilar, Adalimumab, Webcast, Teva, Teva Pharmaceuticals, Generic drug

Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year.

Key Points: 
  • Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year.
  • Alvotech raises topline revenue guidance to $400-$500 million and tightens guidance for bottom line range for 2024 to $100-$150 million.
  • Management will conduct a business update conference call and live webcast on Wednesday May 22, 2024, at 8:00 am ET (12:00 pm GMT).
  • Alvotech will conduct a business update conference call and live webcast on Wednesday, May 22, 2024, at 8:00 am EDT (12:00 pm GMT).

European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14

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金曜日, 5月 24, 2024
Research, Women, Clinical Trials, Biotechnology, Health, Consumer, Pharmaceutical, General Health, Science, European Medicines Agency, Maas, Trial of the century, Safety, Fracture, Marketing, Osteoporosis, Name, EMA, Woman, Biosimilar, OGN, Multimedia, European, Dietary supplement

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar.

Key Points: 
  • Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar.
  • In 2019, it was estimated that 32 million Europeans ages 50 or above had osteoporosis, 25.5 million of which were women.1
    This press release features multimedia.
  • In 2022, Henlius entered into a license and supply agreement with Organon granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14.
  • The agreement covers markets such as the European Union, the United States, and Canada.

Celltrion receives European Commission approval of Omlyclo® (CT-P39), the first and only omalizumab biosimilar approved in Europe

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金曜日, 5月 24, 2024
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Infliximab, Patient, Omalizumab, Pharmacokinetics, Immunology, Food, Sinusitis, European Medicines Agency, FDA, Polyp (medicine), Safety, Marketing, Asthma, Civil service commission, European Commission, CSU, EMA, Allergy, Committee, Biosimilar, CHMP, Pharmaceutical industry

Celltrion today announced that the European Commission (EC) has approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing Xolair®.

Key Points: 
  • Celltrion today announced that the European Commission (EC) has approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing Xolair®.
  • Omlyclo® is approved for the treatment of allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP).
  • This is why we are pleased to receive the first EC approval for an omalizumab biosimilar in Europe, an important step towards improving patient access to treatment.
  • Omlyclo® is Celltrion’s sixth biosimilar, besides Remsima® SC, a subcutaneous formulation of infliximab, approved for use in the EU, following the approval of Remsima® (biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab), and Vegzelma® (biosimilar bevacizumab).

EQS-News: Formycon reports on successful operating business and financial figures for the first quarter of 2024

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金曜日, 5月 10, 2024
FDA, Internet, CFO, Investment, PIN, Fresenius (company), Food, Biosimilar, Pembrolizumab, Depreciation, Johnson & Johnson, Teva, Partnership, Eye, Tax, Ustekinumab, Gulf Cooperation Council, MENA, GCC, Scott Richter, Patient, Acquisition, EMA, Marketing, Novartis, European Medicines Agency, Pharmaceutical industry

Press Release // May 8, 2024

Key Points: 
  • Press Release // May 8, 2024
    Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today published figures for the first quarter of financial year 2024.
  • Formycon confirms the financial guidance issued in April for the 2024 financial year.
  • FYB201 is expected to be marketed under the trade name Ravegza® [2] in Saudi Arabia from the second quarter of 2024.
  • The Management Board of Formycon AG will discuss the development of the company and the key financial figures for the first quarter of the financial year 2024 in a conference call.

Rani Therapeutics Reports First Quarter 2024 Financial Results; Provides Corporate Update

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月曜日, 5月 6, 2024
Biosimilar, Research, Celltrion, Teriparatide, Osteoporosis, Human, Ustekinumab, HC, Patient, Physician, Workforce, SAN, Injection, Pharmaceutical industry

SAN JOSE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter ended March 31, 2024 and provided a corporate update.

Key Points: 
  • SAN JOSE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter ended March 31, 2024 and provided a corporate update.
  • “We are pleased with the progress we have made in the first quarter having announced positive topline results from our Phase 1 study for RT-111.
  • In February 2024, Rani announced RT-111 achieved high bioavailability and was well-tolerated, with no serious adverse events in humans in a Phase 1 study.
  • First Quarter 2024 Financial Results:
    Cash, cash equivalents and marketable securities as of March 31, 2024 totaled $39.6 million, compared to $48.5 million for the year ended December 31, 2023.

Henlius Trastuzumab Receives FDA Approval in the United States

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月曜日, 4月 29, 2024
FDA, NMPA, National Medical Products Administration, European Commission, Biosimilar, European, Patient, Intas Pharmaceuticals, Civil service commission

SHANGHAI, April 29, 2024 /PRNewswire/ -- Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI™ (HLX02, trastuzumab-strf, biosimilar to Herceptin® trade name: HANQUYOU in China and Zercepac® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius.

Key Points: 
  • SHANGHAI, April 29, 2024 /PRNewswire/ -- Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI™ (HLX02, trastuzumab-strf, biosimilar to Herceptin® trade name: HANQUYOU in China and Zercepac® in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius.
  • The product has been approved in the United States (U.S.) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • HLX02 is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and U.S., with previous approvals for commercialisation by the European Commission (EC) and National Medical Products Administration (NMPA) in July 2020 and August 2020, respectively.
  • To date, HLX02 has benefited more than 180,000 patients.

EQS-News: Formycon reports audited annual results for the financial year 2023 – Looking back on a successful operative year and exceeded guidance

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金曜日, 5月 3, 2024
FDA, CFO, Patient, Bank statement, Internet, Web browser, Investment, Zoom, Fresenius (company), Biosimilar, Pembrolizumab, Depreciation, Annual report, Partnership, WACC, Ustekinumab, Development, Tax, EMA, Ranibizumab, Economic development, Marketing, ID, Telephone, COVID-19, Growth, Cryptocurrency

In 2023, we reached all the operational milestones we had set and therewith laid the foundations for a successful and profitable future.

Key Points: 
  • In 2023, we reached all the operational milestones we had set and therewith laid the foundations for a successful and profitable future.
  • Enno Spillner, CFO of Formycon AG, adds: “We have presented excellent financial figures for 2023 and reached or exceeded the guidance.
  • In future reporting, Formycon will replace the previous financial performance indicator "consolidated net result" with the new indicator "adjusted Group EBITDA".
  • The complete Annual Report 2023 can be found on the Formycon website at Financial Reports.