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The Center for Biosimilars Staff
Eye on Pharma: Biocon's Insulin Facility Earns GMP Certification
August 22, 2019
Article
Biocon has gained a certificate of good manufacturing practice (GMP) from the European Medicines Agency’s Irish inspection authority for its Malaysian manufacturing site where it produces its insulin glargine biosimilar, Semglee, referencing Lantus.
Patients With DLBCL See No Additional Gains With Maintenance Rituximab After CHOP
August 21, 2019
Article
A recent study found that rituximab maintenance therapy provides no additional benefit for patients with diffuse large B‐cell lymphoma (DLBCL) who are in complete remission after receiving rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy.
Cummings and Sanders Seek Pricing Information From 3 Generic Drug Makers
August 17, 2019
Article
Representative Elijah Cummings, D-Maryland, and Senator Bernie Sanders, I-Vermont, have sent letters to executives of 3 generic drug makers in which they ask for drug pricing information as part of a probe into the rising cost of generics.
Bio-Thera Begins Phase 1 Study of Proposed Golimumab Biosimilar
August 14, 2019
Article
Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.
Eye on Pharma: FDA Gives Green Light to Aflibercept in Prefilled Syringe
August 14, 2019
Article
Regeneron’s aflibercept (Eylea) has been approved by the FDA for a prefilled syringe (PFS) presentation. The 2-mg, single-dose, PFS will offer the greater ease of use less preparation than the vial presentation of the drug used to treat a range of eye disorders.
With Drug Imports Looming, Questions Raised About FDA Foreign Inspection Program
August 13, 2019
Article
Concerns about overseas inspections continue in the wake of an HHS plan to create 2 potential pathways to allow the importation of some drugs that were intended for foreign markets.
Adoption of Biosimilars Is "Critical" to Combat Cost Increases, Says Vizient
August 08, 2019
Article
In its semiannual drug pricing forecast, healthcare performance company Vizient said that biosimilars will be a key part of combatting rising spending on drugs among its membership.
IGBA's Trade Principles Address Regulatory Convergence and Intellectual Property Concerns
August 07, 2019
Article
The International Generic and Biosimilars Medicines Association (IGBA), which represents generic and biosimilar medicines associations worldwide, recently released its report on how trade agreements can foster generic and biosimilar medicines and improve patient access to care.
Subcutaneous Rituximab Associated With Savings in Time for Patients, Practices Over IV Administration
August 06, 2019
Article
The retrospective analysis of practice care delivery measures at Memorial Sloan Kettering Cancer Center showed substantial time savings for both patients and the healthcare system, researchers report.
To Promote Biosimilars, Cancer Care Ontario Releases Patient Education Handout
August 05, 2019
Article
The fact sheet is being released as Canada awaits the launch of additional anticancer biosimilars.