Latest Biotechnology, Pharmaceutical and Healthcare News from Generics and Biosimilars Initiative

20:45 EDT 22nd October 2018 | BioPortfolio

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Showing News Articles 1–25 of 276 from Generics and Biosimilars Initiative

Friday 19th October 2018

Expediting FDA approvals for biosimilars

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 [1]. Recommendations include allowing smaller batch sizes for testing, encouraging substitution for naïve patients, and removing the requirement for bridging studies.

FDA advisers recommend approval of rituximab biosimilar CT-P10

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.

Platelet reactivity with generic and brand-name clopidogrel

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 [1].

Australia encouraging biosimilars and mandating drug shortage reporting

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.

Biosimilar partnerships for Alvotech and Pall Biotech

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 launches generic tadalafil but delays launch of generic Suboxone

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.

Phase III trial for subcutaneous Remsima completed

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).

Friday 12th October 2018

Comments on FDA’s public meeting on biosimilars

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 darbepoetin alfa biosimilars submitted to Japan’s MHLW

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).

Reasons for switching to biosimilars and immunogenicity

Authors from French universities and hospitals discussed the evidence and issues associated with switching from originator biological to biosimilars [1].

Free prescriptions do not always increase use of generics

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...

Mundipharma buys Spanish biosimilars maker Cinfa Biotech

UK-based Mundipharma International (Mundipharma) is strengthening its position in biosimilars with the acquisition of Spanish biosimilars maker Cinfa Biotech.

European approval for fluticasone/salmeterol and gefitinib generics

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).

FDA approves first drug via Competitive Generic Therapy pathway

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.

EMA aims to improve the availability of medicines in Europe

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.

Friday 5th October 2018

Stakeholder perspectives on biosimilars in oncology

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...

EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca

In September 2018, adalimumab biosimilar, Hulio, and pegfilgrastim biosimilar, Udenyca, received European Commission (EC) approval.

Limited distribution networks found to be anticompetitive

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 [1].

Biosimilars no longer eligible for parallel processing in Australia

Biosimilars will no longer be able to request parallel processing when submitting a biosimilar application for approval in Australia.

Hospitals launch non-profit generics company

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.

Pharmacokinetics of CT-P6 in patients with HER2+ early-stage breast cancer

Researchers from Celltrion presented data that support the pharmacokinetic (PK) similarity between trastuzumab biosimilar CT‑P6 and originator trastuzumab (Herceptin) [1].

FDA releases new guidance to speed up generics approvals

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.

Biocon’s biosimilars plant gains clearance from FDA

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.

Friday 28th September 2018

Bioequivalence of bevacizumab Biosimilar (BEVZ92) versus Avastin in mCRC patients

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) [1].

EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo

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.

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