Generic Drugs

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

Aurobindo has added four cell-culture derived biosimilars to its product line.

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

Dr. Reddy’s has expanded its commercial operations in Europe with the introduction of its range of generic drugs in France.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

A pilot project, beginning in 2017, will support the development of biosimilars.

Reliable, high-quality products require innovative analytics and production.

The biosimilar pathway permits licensure based on less than full clinical data.

Xellia added laboratory space and personnel in Zagreb, Croatia to work on anti-infective products that combat the antimicrobial resistance problem.

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

Alan Sheppard, Principal, Global Generics at IMS Health and CPhI expert panel member, discusses generic medicine opportunities in the 2016 CPhI Annual Industry Report.

Containing costs and improving compliance will be crucial to ensuring the growth of generic pharmaceuticals in the future, says Dilip Shah, CEO of Vision Consulting Group, in CPhI’s 2016 Annual Report, which will be formally issued at CPhI 2016 in Barcelona.

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.

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Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

FDA and industry seek speedy Congressional approval of new user fee plan.

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

Teligent is expanding its manufacturing and R&D complex in New Jersey.

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.

The Office of Generic Drugs highlights the agency’s work to advance generic drugs.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.