Weekend News: Business, Finance and Innovations in Biotech and Pharma Industries
After the relaxing monsoon weekend, check out the news you missed about Biocon and Mylan’s marketing application over biosimilar Pegfilgrastim which will be reviewed by EMA. Check out positive Phase III results of Gilead’s Odefsey for HIV-1 and Amgen and Allergan’s ABP-980 for breast cancer treatment.
Biocon and Mylan’s Marketing Application for Biosimilar Approved for Review by EMA
Biocon Ltd and Mylan’s Marketing Authorization Application (MAA) for the proposed biosimilar Pegfilgrastim used for the reduction of duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (except chronic myeloid leukaemia and myelodysplastic syndromes) has been accepted for review by European Medicines Agency (EMA).
The clinical data included in the application to evaluate the Pharmacokinetic / Pharmacodynamic (PK / PD) and confirmatory efficacy, safety and immunogenicity studies completed earlier in this year. The results are expected to be revealed in the European Society of Medical Oncology (ESMO) Annual Congress to be held in Copenhagen in Oct. 2016.
Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said “The regulatory submission of biosimilar Pegfilgrastim with the EMA by our partner Mylan marks another significant milestone in our journey to develop affordable biologics for cancer patients. Once approved, this product will enable enhanced access to a cost-effective alternative for patients undergoing chemotherapy in the EU. We are committed to bring a diversified portfolio of high-quality, life-enhancing biosimilars to patients globally“.
Gilead’s Odefsey® Positive Result in Phase IIIb Trial for HIV- 1 Treatment
Gilead’s odefsey® intended for the treatment of HIV-1 infection demonstrated significant results in the two Phase IIIb switch studies designed to evaluate the safety and efficacy profile of odefsey in virologically suppressed adult patients switching from the tenofovir disoproxil fumarate (TDF)-based regimens Complera® or Atripla®.
In both studies, Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) showed similar rates of virologic suppression as the TDF-based regimens. Compared to the TDF-based regimens, Odefsey demonstrated statistically significant improvements in bone mineral density (BMD) at the hip and spine in both studies. Improvements in total and tubular proteinuria statistically favored Odefsey in both studies.
Amgen and Allergan’s ABP-980 for Breast Cancer Showed Positive Results in Phase III Trial
Amgen and Allergan’s investigational candidate, ABP-980 showed positive results in Phase III clinical trial conducted for evaluating its safety and efficacy in HER2-positive, early-stage breast cancer patients compared to trastuzumab.
ABP-980 is a biosimilar of trastuzumab which is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody.
“We believe this study confirms no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to continued discussions with regulatory authorities,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Biosimilars are approved based on the analytical, nonclinical and clinical data, and we believe that the totality of the evidence we’ve generated supports ABP 980 as highly similar to the reference product“.
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