Manufacturing, Biosimilars and Biobetters

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

Development and validation of two pivotal assays for in-vitro comparability testing of insulin biosimilars.

PlantForm and PharmaPraxis announce plans to develop six biopharmaceutical targets for the Brazilian market.

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.

High technology assessments are having an impact on biosimilars development in Europe.

Automated sample handling, advanced glycan analysis and specially designed columns are helping biosimilar manufacturers speed up confirmation of the biosimilarity of their products.

Alvotech plans investment in biosimilars portfolio and manufacturing facility.

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.

Review the importance of characterization studies during biosimilars development and related analytical methods.

The California State Assembly becomes the latest state to specify requirements allowing substitution of biosimilars.

Oncobiologics, Inc. and inVentiv Health announced a global strategic partnership around clinical development for all assets in Oncobiologic?s biosimilar pipeline.

Fourth-generation biologics, with improved delivery and pharmacokinetics, will continue to drive an overall biologics industry that is already worth over $120 billion.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.

EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

EMA clarifies biosimilars guidelines.

BioOutsource, a contract testing services provider to the biopharmaceutical industry, has opened a new facility in Cambridge, Massachusetts. The facility marks the company's first North American offices, which were opened in response to increasing demand for the company's bioanalytical and biosafety services, particularly in the field of biologic and biosimilar characterisation.

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products.

Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.

Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.

FDA has released a list of more than 50 guidance documents planned for 2013.

FDA has released a list of more than 50 guidance documents planned for 2013.

Development requirements and regulatory guidance for biosimilars and biobetters.

FDA talks about the changing scope of regulatory science.

Neil Lewis, chief technology officer at Malvern Instruments, talks about the challenges associated with biologics.

Can postapproval FDA filings immunize pharma companies from patent lawsuits?

AET BioTech and BioXpress Therapeutics have entered into an agreement to codevelop a biosimilar version of Abbott's tumor necrosis factor inhibitor monoclonal antibody adalimumab.