Biosimilars

The AJMC^® Biosimilars compendium is a comprehensive resource for news and expert insights into these biological products, including clinical research, patent and legal news, and regulatory updates.

Latest News

FDA approval with stamp. | Image Credit: Surendra - stock.adobe.com

FDA Approves Seventh Ustekinumab Biosimilar to Reference Stelara

By Cameron Santoro

December 20th 2024

The FDA granted approval to Steqeyma (ustekinumab-stba) for inflammatory conditions, making it the seventh biosimilar to reference Stelara after a year of multiple ustekinumab biosimilar approvals.

AJMC

Uptake of Rituximab Biosimilars in Medicare and Medicaid in 2019-2022

By Jingjing Qian, PhD

December 16th 2024

Seattle Washington skyline | Image Credit: © espiegle - stock.adobe.com

From Approval to Practice: Addressing the Hurdles in Biosimilar Integration

By Skylar Jeremias

December 12th 2024

Health Policy. | Image Credit: Mohamad Zaki - stock.adobe.com

Policy Proposals Aim to Stimulate the Long-Term Sustainability of Infused Biosimilars

By Cameron Santoro

December 4th 2024

FDA approval. | Image Credit: syahrir - stock.adobe.com

FDA Approves Sixth Ustekinumab Biosimilar, Yesintek

By Skylar Jeremias

December 2nd 2024

More News

Engaging Patients in Oncology Trials Is a Team Effort

May 10th 2017

Engaging Patients in Oncology Trials Is a Team Effort

What Will Patients Gain From the TAPUR Study?

May 10th 2017

What Will Patients Gain From the TAPUR Study?

Drug Price Arguments Have No Easy Answer

May 10th 2017

Drug Price Arguments Have No Easy Answer

Empowering Stakeholders with Innovative Trial Designs

May 10th 2017

Empowering Stakeholders with Innovative Trial Designs

Center of Excellence: Streamlining Drug Approvals

May 10th 2017

Center of Excellence: Streamlining Drug Approvals

FDA Center of Excellence and the Drug Approval Process

May 10th 2017

FDA Center of Excellence and the Drug Approval Process

Drug Price Negotiation by CMS

May 10th 2017

Drug Price Negotiation by CMS

Improving the Drug Approval Process to Reduce Drug Costs

May 10th 2017

Improving the Drug Approval Process to Reduce Drug Costs

Off-Label Communications to Inform Formulary Management

May 10th 2017

Off-Label Communications to Inform Formulary Management

Considerations With Off-Label Communication

May 10th 2017

Considerations With Off-Label Communication

Evidence From Drug Manufacturers and Patient Access

May 10th 2017

Evidence From Drug Manufacturers and Patient Access

Off-Label Communications: What It Means for Stakeholders

May 10th 2017

Off-Label Communications: What It Means for Stakeholders

February 27th 2017

What We're Reading: Single-Payer Plan in Calif.; New Mexico Biosimilar Bill; and Shared Decision Making

October 10th 2016

Biosimilars and Interchangeability: Evolving Understanding and Regulations

Laura Joszt, MA

The FDA has already approved 4 biosimilars in the United States, but there remains a lot of uncertainty surrounding some of the legislation and regulation.

October 7th 2016

5 Key Takeaways From AMCP Nexus 2016

Laura Joszt, MA

Specialty pharmacy pipelines, healthy behaviors, and regulation took the stage at the Academy of Managed Care Pharmacy (AMCP)’s 2016 Nexus conference, which was held October 3-6 in National Harbor, Maryland.

September 28th 2016

Participating Faculty

September 23rd 2016

UnitedHealth's 2017 Formulary to Support Generic and Biosimilar Drugs

Surabhi Dangi-Garimella, PhD

UnitedHealth has posted a presentation on its website that provides an update to its pharmacy benefits and prescription drug lists for 2017.

August 8th 2016

PBMs Create a Path for Me-Too Drugs, Biosimilars on Their Oncology Formulary

Surabhi Dangi-Garimella, PhD

Pharmacy benefit managers (PBMs) and large employer organizations are taking measures to save healthcare costs in 2017, and for PBMs, formulary exclusions is a fool-proof tactic.

July 6th 2016

What We're Reading: VA Healthcare Operations Still Require "Urgent Reform"

What we're reading, July 6, 2016: the Department of Veterans Affairs has made progress, but still has a long way to go; court upholds 6-month delay for biosimilars; and Apple promotes organ donation with iPhone app.

June 24th 2016

What We're Reading: How Brexit Could Impact Drug Regulation

What we're reading, June 24, 2016: Britain's decision to leave the European Union will impact drug regulation; Supreme Court decision derails California proposal to allow illegal immigrants to buy health insurance; and lawmakers look to reduce exclusivity period for biologics.

June 21st 2016

Industry Insight on the Challenges With Developing and Adopting Biosimilars

Surabhi Dangi-Garimella, PhD

At the annual meeting of The Community Oncology Alliance, oncologists sat through a crash course on biosimilars that was rendered by experts from the pharmaceutical industry.

Dr Aimee Tharaldson Expects the Biosimilar Approval Process to Pick Up Speed

June 10th 2016

Dr Aimee Tharaldson Expects the Biosimilar Approval Process to Pick Up Speed

The process for approving biosimilars has been moving slowly, but Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapies at Express Scripts, foresees them as having the potential to lower costs for the industry and hopes the approval process will pick up speed.

Dr Pamela Becker: Bar Is Set Very High to Meet Biosimilar Definition

May 25th 2016

Dr Pamela Becker: Bar Is Set Very High to Meet Biosimilar Definition

The bar is set very high in terms of the biosimilar requirement definition, and physicians who are hesitant about substituting biosimilars for treatment should not be worried about the perceived differences, according to Pamela S. Becker, MD, PhD, professor of medicine in the Division of Hematology at the University of Washington School of Medicine.

May 5th 2016

Adoption of Biosimilars: Prescriber, Pharmacy and Payer Perspectives

May 3rd 2016

Dr Jeremy Schafer Discusses Paying for Biosimilars and Patient Education

Jeremy Schafer, PharmD, MBA, vice president and director of specialty solutions at Precision For Value, discussed a number of important topics regarding biosimilars, including how he expects the US will have an easier time approving biosimilars and the importance of patient education about biosimilars.

April 19th 2016

What We're Reading: Theranos Now Subject of a Criminal Investigation

What we're reading, April 19, 2016: blood-testing laboratory Theranos is now facing a criminal investigation; biosimilars may not be cheaper than brand name biologics for some seniors; and stigma and misconceptions remain regarding palliative care.

Dr Jeremy Schafer Discusses the Importance of Immunogenicity of Biosimilars

April 19th 2016

Dr Jeremy Schafer Discusses the Importance of Immunogenicity of Biosimilars

The FDA recently approved the biosimilar infliximab and found that from an immunogenicity profile it was more or less similar, which is important for payers and providers, explained Jeremy Schafer, PharmD, MBA, vice president and director of specialty solutions at Precision For Value.

April 15th 2016

Industry Insight on the Challenges With Developing and Adopting Biosimilars

Surabhi Dangi-Garimella, PhD

Pharmaceutical industry experts provide an overview of the highly complex biosimilar development process at The Community Oncology Conference: Innovation in Cancer Care, held in Orlando, Florida.

April 13th 2016

Adoption of Biosimilars: Prescribers, Pharmacy and Payer Perspectives

April 1st 2016

NCCN Has Faith in the Potential of Biosimilars

Surabhi Dangi-Garimella, PhD

While these "generic" biologicals have been deemed to have the potential to create competition and result in healthcare savings-although not to the extent of generic products-technical issues with manufacturing these products have troubled drug manufacturers.

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