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Here are the most relevant search results for "Generics and Biosimilars Initiative" found in our extensive news archives from over 250 global news sources.
In addition to our news stories we have dozens of PubMed Articles about Generics and Biosimilars Initiative for you to read. Along with our medical data and news we also list Generics and Biosimilars Initiative Clinical Trials, which are updated daily. BioPortfolio also has a large database of Generics and Biosimilars Initiative Companies for you to search.
A number of recommendations for the US Food and Drug Administration (FDA) to simplify biosimilar licensing laws, and thus make biosimilars more accessible, are offered in a recent review . Recommendations include allowing smaller batch sizes for testing, encouraging substitution for naïve patients, and removing the requirement for bridging studies.
US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for CT‑P10, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). If approved by FDA, this would be the first rituximab biosimilar approved in the US.
The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. However, there is a lack of information about inhibition of platelet reactivity by generic preparations. A study was therefore carried out using both generic and brand-name clopidogrel to compare the platelet reactivity .
In an effort to address both the rising prices of medicines and the risk of drug shortages in Australia the country has introduced drivers to encourage the use of biosimilars and mandatory reporting of drug shortages.
Partnering to develop biosimilars is still in vogue. The latest companies to join the trend include Alvotech with Changchun High & New Technology Industries Group (CCHN) and Pall Corporation’s Biotech business (Pall Biotech) with Aetos Biologics.
Teva Pharmaceutical Industries (Teva) announced in September 2018 that it was launching generic tadalafil but would be delaying the launch of its higher-dose Suboxone (buprenorphine/naloxone) generic.
Celltrion Healthcare (Celltrion) announced on 29 August 2018 that it had completed a phase III study with the subcutaneous (SC) version of its infliximab biosimilar Remsima (CT‑P13).
Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeability information in the Purple Book, criticism of FDA’s use of arbitrary suffixes and a request to waive bridging studies for biosimilars.
Two South Korean firms have announced that they have submitted applications for approval of their proposed darbepoetin alfa biosmilars to Japan’s regulatory agency, the Ministry for Health Labour and Welfare (MHLW).
Authors from French universities and hospitals discussed the evidence and issues associated with switching from originator biological to biosimilars .
One strategy to increase the use of generics is to offer them free-of-charge. This strategy presumes that this will shift demand away from expensive brand-name drugs and produce savings for insurers and customers alike. In order to test this theory, researchers from the University of Maryland studied co-payment data from Medicare recipients# to see if offering zero generic co-pays for oral antidia...
UK-based Mundipharma International (Mundipharma) is strengthening its position in biosimilars with the acquisition of Spanish biosimilars maker Cinfa Biotech.
Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 10 September 2018 that its subsidiary Glenmark Arzneimittel had secured marketing authorization in Germany for its generic fluticasone/salmeterol dry powder inhaler (DPI).
The US Food and Drug Administration (FDA) announced on 8 August 2018 that it had approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canada-based Apotex’s potassium chloride oral solution.
A European Union (EU) task force, which was set up by European regulators, has published its work programme for 2019/20 and announces a multi-stakeholder workshop.
Monoclonal antibody biosimilars represent a novel advance in the field of oncology, and their integration into routine clinical practice present challenges for clinicians, nurses, patients and regulators. Researchers therefore investigated the perspectives stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist on optimizing the uptake of monoclonal antibody...
In September 2018, adalimumab biosimilar, Hulio, and pegfilgrastim biosimilar, Udenyca, received European Commission (EC) approval.
Limited distribution networks, whereby a drug manufacturer has a contract with one or a small number of distributors, suppress competition in both the generic and biosimilar drug markets. This leads to high costs for both payers and patients, according to a recent US review .
Biosimilars will no longer be able to request parallel processing when submitting a biosimilar application for approval in Australia.
Several major hospital groups announced the official launch of their non-profit generics company, Civica Rx, on 6 September 2018. The company has been created in an effort to combat regular shortages and the increasing prices of drugs.
Researchers from Celltrion presented data that support the pharmacokinetic (PK) similarity between trastuzumab biosimilar CT‑P6 and originator trastuzumab (Herceptin) .
The US Food and Drug Administration (FDA) has released a guidance document that aims to reduce the time that it takes for safe and effective generics to reach the market.
India-based biologicals specialist Biocon has stated that its biosimilars plant has received a clean bill of health, indicating that it is now compliant with US Food and Drug Administration (FDA) manufacturing requirements.
Researchers from mAbxience presented data that supports the pharmacokinetic (PK) bioequivalence between bevacizumab biosimilar BEVZ92 and originator bevacizumab (Avastin) as first-line treatment in combination with fluorouracil, leucovorin and oxaliplatin (FOLFOX) or fluorouracil, leucovorin, and irinotecan (FOLFIRI). in patients with metastatic colorectal cancer (mCRC) .
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 September 2018 that it had recommended granting of marketing authorizations for the pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo.