Why Should We Rescue The Legislative Intent Of The BPCIA?

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.

Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book

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.

New US Legislation Creates Momentum For Biosimilars

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.

Peptides: Best Practices On Regulatory & Control Strategies, Analytical Methods, & More

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.

Outlook: Biotech In 2021 & Beyond

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.

No, Biologics Are Not Natural Monopolies

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.

Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across

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.

Assessing CT-P13 SC’s Impact Across Indications

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.

Subcutaneous Infliximab In The U.S.: Defining CT-P13 SC’s Competitive Edge

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.

The Biosimilar Leadership Playbook: 5 Tips For Success

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. 

The Opportunities & Challenges Of India’s Biologics Market

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.

Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?

In this fourth installment of the Editorial Board 2021 Outlook, it's clear that stakeholders are relying more heavily on biosimilars and that it’s more important than ever for biosimilar companies to keep carrying the torch for more competition, cost-savings, value, and responsible pricing.

The Top 5 Biosimilar Developments Of 2020

Though 2020 felt like an endless descent into Dante’s Nine Circles of Hell, I wanted to end the year as I typically do: with a column highlighting the most important and positive biosimilar developments from the past 12 months.

The Second Wave Of Biosimilars: New Scenarios, New Rules

The arrival of what we could call the first “bio patent cliff” has revealed important lessons that should be taken into consideration when selecting new candidates for the second and third waves.

Biosimilar Experts Reflect On 2020’s Greatest Biosimilar Achievements

As the amazing members of the Biosimilar Development Editorial Board emphasize here, there is a lot to be thankful for in the biosimilar world. Check out the first of what will be a four-part series showcasing the editorial board’s thoughts on the past year and the year(s) ahead.

Accelerate Your Pipeline With CDMO Collaboration

Collaborating with a CDMO can augment your capacity and expertise, refine your processes, and ultimately shorten your time to market. This ebook offers best practices that make working with a CDMO as efficient as possible.

3 Expert Perspectives On Biosimilar Differentiation & Biobetter Development

In part two of this two-part series, several experts from a DIA panel share additional insights around the types of differentiation biosimilar companies can pursue and its overall impact on product/device selection and the manufacturing process. 

Biosimilar Or Biobetter? Perspectives On An Evolving Market

A recent webinar from IQVIA on the biosimilar and “biobetter” landscape provided a great overview of the opportunities for differentiation and the outlook for biobetter development. In part one of this two-part article on differentiation, I’ll share some of my main takeaways from IQVIA’s webinar.

Will Biosimilar Manufacturers Pursue Lower-Revenue Products?

Will biosimilar makers have any motivation to develop biosimilar competitors for biologics earning considerably less in U.S. sales than previous generations? Biosimilar Development decided to do a deeper dive into one of these products, which may represent a broader base of biologic agents beyond autoimmune and oncology agents.

IQVIA’s U.S. Biosimilar Report: Your Most Pressing Questions Answered

In recent weeks, there have been several reports released on the current state of the U.S. biosimilar market — including IQVIA's "Biosimilars in the U.S. 2020-2024." Overall, there were a few data points from this report I thought were worth singling out and discussing a bit further. 

Mapping The Development Of A Biosimilar Candidate: Analytical & Regulatory Decisions

This article, the first in a two-part series, details the biosimilar development path to identify and evaluate critical quality attributes for both the candidate biosimilar and the reference product, along the regulatory timeline.

Biosimilars: The New World Of Commercialization

Great changes are afoot in the world of biosimilar commercialization. Here, Abraxeolus Consulting manager Edric Engert walks you through his view as to what has been, what has changed, and what the new flexible biosimilar business model of the future will look like.

The Past, Present, & Future of Biosimilar Manufacturing

A recent publication entitled "Approval of Biosimilars: A Review of Unsuccessful Regulatory Filings" revealed the most common manufacturing issues the FDA and EMA flagged in biosimilar applications. Here, the lead author discusses his findings from the past, current manufacturing challenges, and which technologies could be most impactful for the future biosimilar industry.

Droplet Digital PCR Applications Guide

Droplet Digital polymerase chain reaction (ddPCR™) was developed to provide high-precision, absolute quantification of nucleic acid target sequences with wide-ranging applications for both research and clinical diagnostic applications. ddPCR measures absolute quantities by counting nucleic acid molecules encapsulated in discrete, volumetrically defined water-in-oil droplet partitions. Droplet Digital PCR using Bio-Rad’s QX100™ or QX200™ Droplet Digital PCR system overcomes the previous lack of scalable and practical technologies for digital PCR implementation.

Viral Quantification - Adeno-Associated Virus Vector Genome Titer Assay

Recombinant adeno-associated virus (AAV) is rapidly becoming the vector of choice for human gene therapy applications due to the ability to achieve prolonged gene expression in a variety of tissues without a significant immune response or toxicity. Large-scale manufacture of AAV vector for clinical trials requires a high degree of sophistication in both process design and lot release assays. Read how ddPCR represents a highly precise method to determine AAV vector genome titers and is not unduly influenced by inefficient amplification or standard curve issues.

Private Equity: A New Pillar For Biosimilar Development?

The emergence of the biosimilar market represents an interesting opportunity for private equity firms in the global healthcare landscape. Here are the biggest deals from the last two years that suggest there is growing willingness outside of government funding to invest in biosimilar development — especially in emerging markets. 

Weighing The Potential Of Humira Biosimilars In The U.S. — Expected Winners And Losers

This is the second article in a two-part series exploring the anticipated competitive landscape for Humira (adalimumab) biosimilars following their U.S. launch in 2023. In this part, we evaluate the potential for individual adalimumab biosimilar products, comparing and contrasting the agents based on a number of important factors, including order of market entry, company resources and reputation, and product characteristics.

Counting DNA Molecule By Molecule

Digital PCR is an established nucleic acid (NA) quantification technology, which enhances the broad use of PCR across molecular biology laboratories globally through improved precision and accuracy. Organizations that impact the quality of nucleic acid measurement and testing, adopted digital PCR early on and have since been pioneering its use for improved accuracy and precision in NA measurement. Ultimately, this will positively impact the quality of NA measurements generally and, more specifically, clinical NA testing. Molecular counting of nucleic acid molecules is the next measurement paradigm.

Weighing The Potential Of Humira Biosimilars In The U.S.

This two-part article series explores the factors differentiating the Humira (adalimumab) biosimilar market from that of infliximab biosimilars, which could lead to stronger uptake of these products in the U.S. In Part 1, we focus on the unique competitive dynamics within the adalimumab biosimilar market.

Biosimilar News You May Have Missed During COVID-19

There have been a few exciting pieces of news and industry movements that are worth noting as we approach fall. I anticipate these topics will continue to come up and/or shape biosimilar conversations in the years ahead.