Generic Drugs

Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

FDA approves a biosimilar and loses a commissioner in March.

Drug makers back alternative to FDA labeling update rule.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.

Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.

FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.

Remsima will now be available for patients in 12 additional countries in the European Union.

Bristol-Myers Squibb announced that it reached an agreement to acquire Flexus Biosciences and has entered into a $309-million partnership with Rigel Pharmaceuticals.

Celltrion announced that its Remicade biosimilar, Rensima, could save France, Italy, and the UK up to €336 million in costs to treat Crohn’s disease.

Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.

Ligand-binding assays are fundamental to characterizing biosimilars.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Market forces may limit the success of CMOs.

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

FDA opens public docket on proposed criteria for “first generic” ANDAs.

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.

The total market for biopharmaceuticals in 2013 was $36.8 billion according to Kalorama Information. Meanwhile, Frost & Sullivan estimates that the biosimilars market, which it pegged at just $1.2 billion in 2013, will grow to $23 billion in 2019, or more than 20-fold increase.

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.