Biosimilars and Biobetters

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.

Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Specialist biopharmaceutical company, Alvotech, has announced receipt of a manufacturing license from the Icelandic Medicines Agency, applying to its biopharmaceutical facility based in Reykjavik, Iceland.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

The company’s biosimiliar to Amgen’s Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The collaboration will focus on developing manufacturing solutions for biosimilars.

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

The European Commission (EC) approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin, to treat certain breast and gastric cancers.

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

The recommended drugs include two orphan medicines and three biosimilars.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.

CPhI Korea to feature zone for finished dosage formulation drug products.

Biogen will pay Samsung BioLogics approximately $700 million to increase its stake in Samsung Bioepis to approximately 49.9%.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

Safeguarding the know-how behind biopharmaceutical innovation is crucial to the industry’s future, but, in the US, some argue it is becoming increasingly difficult to do.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

The agency has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.