Biosimilar Development solution center
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Subcutaneous Infliximab In The U.S.: Defining CT-P13 SC’s Competitive Edge
3/17/2021
TNF inhibiting biologics still reign supreme when treating immunological diseases. GlobalData believes that Celltrion’s CT-P13 SC will likely see better success than IV infliximab biosimilars in the U.S. In Part 1 of this two-part article series, we assess the factors that may give CT-P13 SC a competitive edge over Remicade and IV infliximab biosimilars.
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The Biosimilar Leadership Playbook: 5 Tips For Success
2/10/2021
In the next five to 10 years, what will define a leader in the biosimilar space? Which skills will be the most important to long-term growth in the biosimilar space? Here McKinsey & Co.'s Jorge Santos da Silva shares five specific best practices emerging for any company looking to be — or remain — a leader in the biosimilar space.
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The Opportunities & Challenges Of India’s Biologics Market
1/27/2021
Biosimilar drugs, due to their affordability, can play an important role and allow the Indian government to have a better healthcare system. However, as issues remain on the regulatory and manufacturing sides, India needs to see strong improvements to compete and appear as an important hub nationally and internationally.