Biosimilar Development solution center

41. B. Cepacia: A Case Study For Determining Objectionableness In Drug Manufacturing 8/9/2021

    After introducing the subject of colonization and opportunistic pathogenicity in part 1 of this 2-part series, the authors return to discussing B. cepacia in more depth in this article.

42. Objectionableness: How To Know If A Microorganism Poses A Risk In Your Drug Product 8/6/2021

    It is important to consider at the beginning of an exploration of species “objectionableness” in microbiological analysis that this idea is unique to our specific corner of the world. If you search for a definition of objectionable organisms in a microbiology reference text, you are unlikely to find one. This article, as part 1 in a 2-part series, meets that need.

43. Why Should We Rescue The Legislative Intent Of The BPCIA? 7/28/2021

    What happens when regulatory ambiguity displaces sound scientific guidance, deterring the legislative intent of Congress? This is precisely the situation regarding the FDA changing the regulatory rules of the road regarding a biosimilar’s strength versus its potency.

44. Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book 7/12/2021

    The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.

45. New US Legislation Creates Momentum For Biosimilars 6/25/2021

    Most biosimilars (follow-on biologic products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.

46. Peptides: Best Practices On Regulatory & Control Strategies, Analytical Methods, & More 6/18/2021

    Industry, regulatory, and academic experts recently gathered at the United States Pharmacopeial Convention’s (USP’s) annual Peptides & Oligonucleotides Workshop virtually to share best practices on chemistry, manufacturing, and controls (CMC) for peptides. This article summarizes discussion highlights.

47. Outlook: Biotech In 2021 & Beyond 5/31/2021

    Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.

48. No, Biologics Are Not Natural Monopolies 4/28/2021

    Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.

49. Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across 3/31/2021

    Biosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.

50. Assessing CT-P13 SC’s Impact Across Indications 3/24/2021

    This is the second article in a two-part series exploring the anticipated competitive dynamics for Celltrion’s subcutaneous (SC) infliximab bio-better, CT-P13 SC, in the U.S.The author explores how market dynamics across different autoimmune indications will drive distinct uptake of CT-P13 SC, highlighting the potential impact on TNF inhibitor competition.