Latest Conference Articles

In the Effort to Develop Global Comparator Products, Biosimilars Lead the Way

Kelly Davio

February 1 2019

Biosimilars are often described as lagging behind generic drugs because there are fewer in the market and they have lower acceptance and uptake. However, according to stakeholders who spoke during the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, biosimilars are leading the way in the effort to create global comparator products for use in drug development.

With 8 Weeks Left Before Brexit, Stakeholders Urge Action

Kelly Davio

January 31 2019

One of the most time-sensitive topics at this week’s Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, was preparing for the United Kingdom’s upcoming withdrawal from the European Union.

Regulators and Drug Makers Call for Greater International Regulatory Alignment

Kelly Davio

January 31 2019

On the opening day of the Medicines for Europe (MFE) 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, representatives of the generics and biosimilars industry and regulators gathered to discuss the opportunities and challenges posed by the globalization of medicine development and manufacture.

Is It Time for a Global Reference Product for Biosimilars?

Allison Inserro

January 26 2019

On the last day of the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, the head of the FDA practice at Avalere discussed her point of view that enabling a global reference product for biosimilars would provide global access for patients.

Managing Risk Can Ensure Biosimilar Rewards, Expert Says

The Center for Biosimilars Staff

January 24 2019

Despite the challenges inherent in biosimilars, they have a fairly high probability of success, said Edric Engert, managing director of Abraxeolus Consulting, in a presentation at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.

Businesses Have a Financial Stake in Promoting Biosimilars, Employer Groups Say

Allison Inserro

January 24 2019

At a panel discussion at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, representatives of employer groups discussed the role that businesses have in driving the discussion about raising awareness and adoption of biosimilars. Employer groups can help overcome barriers, such as patient fears and misinformation, and create confidence about using biosimilars, speakers said.

Creating and Sustaining Best Practices in Launching Biosimilars

Allison Inserro

January 24 2019

Before launching into a discussion of what firms need to consider when identifying “best practices” to get a biosimilar up and running in a new market, Mylan’s global commercial head for biologics and insulin gave a quick history lesson about how far the field has come in a keynote address at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.

What's New in Medicare Part B for Biosimilars

Allison Inserro

January 23 2019

The current administration in Washington, DC, is one of the most active when it comes to policy and regulation that affects biosimilars, said a presenter who recapped recent changes for the attendees at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.

At J.P. Morgan Healthcare Conference, Mylan, Momenta, and AbbVie Discuss the Role of Biosimilars

Kelly Davio

January 10 2019

During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, drug makers Mylan and Momenta explained the role that biosimilars will play in their growth, while AbbVie outlined its strategy for managing direct biosimilar competition.

FDA's Scott Gottlieb, MD, Highlights Biosimilars Initiatives in J.P. Morgan Keynote Address

Samantha DiGrande

January 9 2019

During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, FDA Commissioner Scott Gottlieb, MD, delivered a keynote address encompassing his goals for the direction of the FDA in the coming year.