Biologics & Biosimilars

DMARDs for rheumatoid arthritis linked to lower dementia risk

April 12, 2024 - Research published in Rheumatic & Musculoskeletal Disease found that patients with rheumatoid arthritis (RA) who were taking biological disease-modifying antirheumatic drugs (DMARDs) had a 24% lower risk of dementia. Previous studies have linked RA with an elevated risk of dementia, identifying chronic systemic inflammation and dysregulation of...

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Developing Quality Assurance Standards for Biologics, Biosimilars

by Veronica Salib

Biologics and biosimilars are a rapidly growing sector of the biopharmaceutical industry. However, as the field grows, multiple challenges arise in the manufacturing and quality assurance guidelines for biologics and...

Advancing Packaging Technologies for Climate-Adaptive Supply Chains

by Alivia Kaylor

The global climate crisis poses significant challenges to the biopharmaceutical industry, particularly regarding packaging and temperature control. The increasing unpredictability of weather patterns can lead to fluctuations in temperature...

Combating Specialty Drug Challenges in the Pharmaceutical Industry

by Editorial Staff

The pharmaceutical industry has witnessed a significant rise in the utilization of specialty drugs in recent years, prompting a need for improved cost management and a streamlined patient experience. Specialty drugs, characterized by their...

First FDA-Approved Biosimilar for Multiple Sclerosis Mimics Tysabri

by Veronica Salib

On August 24, 2023, the United States Food and Drug Administration approved Tyruko, natalizumab-sztn, a biosimilar for Tysabri (natalizumab), an injectable biologic for managing multiple sclerosis. The...

Eli Lilly Announces $2.4B Acquisition of Immunology Company Dice Therapeutics

by Hayden Schmidt

Monday, Eli Lilly announced that it would acquire Dice Therapeutics for $2.4 billion in cash, representing a 40% premium on the recent trading value of the smaller firm. Lilly’s purchase...

FDA Grants Bluebird Bio Priority Review of BLA for SCD Treatment

by Veronica Salib

On June 21, 2023, Bluebird Bio issued a press release announcing that the FDA had granted its biological license application (BLA) for a new sickle cell disease (SCD) treatment priority review...

Top Challenges Facing Biosimilar Adoption and Manufacturing

by Veronica Salib

Biosimilar adoption by the healthcare industry can incentivize pharmaceutical development and increase options for patients, payers, and providers by offering a less expensive alternative to biologic...

How Inflation, Competition, Biosimilars Affect Prescription Drug Costs

by Editorial Staff

As the inflation rate continues to rise, the healthcare industry — like every other industry — is taxed with extraordinarily high costs. Rising drug prices have caused increased healthcare expenditures and out-of-pocket costs....

Comparing Small Molecule and Biologics Drug Development Challenges

by Veronica Salib

In recent years, pharmaceutical industry members have identified a boom in the biologic and biosimilar space. Although they only comprise a small part of the pharmaceutical industry, biological drug...

Abbvie Faces Competitor as a New Humira Biosimilar Comes to Market

by Veronica Salib

On January 31, 2023, Amgen announced that its product AMJEVITA, a Humira biosimilar, is now available in the United States. This new availability threatens the stake that AbbVie has held for decades...

The FDA Modernization Act 2.0 Allows Animal Trials Alternatives

by Veronica Salib

On December 29, 2022, President Biden signed the FDA Modernization Act 2.0 into law, allowing clinical trial leaders to use animal trial alternatives before human clinical trials. Senators Rand Paul,...

ACMA Announces Board Certification Program for Biologics, Biosimilars

by Veronica Salib

Biosimilars have gained significant traction in healthcare for being more affordable alternatives to biological products. Despite the importance and benefits of biosimilars, many providers are hesitant...

Biosimilars in the US Cost 2.74 Times More Than in Other Countries

by Veronica Salib

Biosimilars, biologic products similar to brand-name biologics, are praised as a less expensive alternative for patients with chronic diseases requiring biologics. Many providers and healthcare experts...

Anticipating the 2023 Biosimilar Boom

by Veronica Salib

A recent analysis by Vantage Market Research found that in 2021 the global biosimilars market was valued at $28.46 billion. Projections based on market trajectory predict that the market will surpass $103.94 billion by 2028. While...

Understanding Differences between Generic, Brand Name, Biosimilars

by Veronica Salib

Every day patients, payers, and providers must navigate the pharmaceutical industry to obtain and deliver treatment. Unfortunately, the industry is full of language and nuances that make this process unnecessarily difficult. When providers...

Biologics and Biosimilars Intelligence Consortium Awarded $1.3 Million

by Veronica Salib

On October 3, 2022, the FDA awarded the Biologics and Biosimilars Collective Intelligence (BBIC) a $1.3 million grant to be paid out in the next two years. The grant is intended to fund a study on...

Biosimilars Have Saved $12.6 Billion in the US between 2014 and 2022

by Veronica Salib

Biosimilars are gaining new traction in the pharmaceutical industry as a tool for providers and patients to manage diseases. The National Cancer Institute defines a biosimilar drug as a “biological drug that is very much like another...

FDA Accepts Biologic Application for Keytruda Treatment of Lung Cancer

by Hayden Schmidt

The FDA recently accepted Merck’s Biologics License Application (BLA) for its cancer medication Keytruda. Promising results from interim clinical trial data indicated that Keytruda improved...

Eli Lilly Sued by Whistleblower for Pharmaceutical Manufacturing Issue

by Hayden Schmidt

A former employee of Eli Lilly is suing the company, claiming she was terminated after exposing issues with pharmaceutical manufacturing practices at one United States operation. Amrit Mula said that...

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