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While Europe may be one regulatory jurisdiction, covered by the European Medicines Agency, each European nation must forge its own path in encouraging biosimilar adoption and competition. During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a variety of stakeholders addressed how their respective countries are addressing the need for policies to encourage biosimilars.

Ned Pojskic, leader of pharmacy and health provider relations at the not-for-profit Green Shield Canada, the fourth largest private payer in Canada, discussed his organization’s efforts toward broad biosimilar adoption.

During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Steinar Madsen, MD, director of the Norwegian Medicines Agency (NoMA) and self-described “spiritual father” of the NOR-SWITCH study, gave a presentation on the sustainability of the biosimilars market in Europe.

Often left out of the discussion about switching to biosimilars is the perspective of a particularly key stakeholder group: patients. During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21-22 in Porto, Portugal, Francois-Xavier Frapaise, MD, principal of F.-X. Frapaise Consulting, sought to describe current challenges and emerging solutions in gaining patients’ trust in biosimilars and suggested that biosimilars can be an opportunity to “resuscitate the social contract.”

During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, João Gonçalves, PhD, group leader and principal investigator at Research Institute for Medicines in Portugal, discussed ways in which biosimilar developers can anticipate—and avoid—issues with immunogenicity.

While much attention is paid to the US and European biosimilars markets and the benefits that biosimilars could accrue for patient access and cost reduction, other large regulatory jurisdictions, including those with limited healthcare resources, could also benefit from these products. However, bringing biosimilars to countries outside of European Medicines Agency (EMA) or FDA authority has its unique challenges.

Nikolai C. Brun, MD, PhD, chief medical officer and director of the division of medical evaluation and biostatistics at the Danish Medicines Agency, shared how his national agency has actively worked to adopt and benefit from biosimilars, and provided a clear reminder of the fact that biosimilar uptake does not occur without concerted effort on the part of stakeholders.

During the first day of the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Barbara Valenta-Singer, MD, chief medical officer of biosimilars at Fresenius-Kabi SwissBioSim, gave an expert perspective on the past 10-plus years of experience with biosimilars in the European and US contexts.

During this week’s 14th Congress of the European Crohn’s and Colitis Organisation, multiple research teams reported on efforts to better understand the factors that impact adalimumab therapy in patients with inflammatory bowel disease (IBD).

Celltrion, maker of biosimilar infliximab CT-P13 (Remsima, Inflectra), has recently submitted an application to the European Medicines Agency for a subcutaneous formulation of the biosimilar.

The advent of biosimilar adalimumab in the European Union was among the most eagerly awaited events for biosimilar stakeholders in 2018. During this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, research teams are presenting findings concerning antidrug antibody (ADA) development related to adalimumab and therapeutic drug monitoring (TDM) of one of those adalimumab biosimilars: Amgen’s ABP 501, sold in the European Union as Amgevita.

In patients with ulcerative colitis and Crohn disease, treatment with biologics is often effective, but adverse events or loss of response may lead to discontinuation. Several studies that will be presented at this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, sought to investigate factors related drug survival and discontinuation of biologic therapies for inflammatory bowel disease (IBD).

This week, the European Crohn’s and Colitis Organisation (ECCO) will hold its 14th Congress in Copenhagen, Denmark. During the meeting, which runs from March 6-9, experts will gather from around the globe to discuss significant medical research into the treatment of inflammatory bowel disease (IBD), and numerous researchers will present findings on real-world switches to biosimilar infliximab CT-P13 (Inflectra, Remsima).

During the Association for Accessible Medicines’ Access! 2019 meeting, Doug Long, vice president of industry relations at IQVIA, gave an update about what trends are being identified in the generic and biosimilars markets across the globe.

Addressing the rising cost of drugs in the United States has become a problem that many entities and stakeholders are hoping to solve. From the federal government down to the state level, everyone seems to be taking the problem into their own hands.

HHS Secretary Alex Azar offered a view of hope and optimism for the future of the American healthcare market in his remarks delivered as the closing keynote address at the Association for Accessible Medicine’s Access! 2019 meeting.

“Today’s healthcare system is unsustainable. [US] national health spending is expected to grow at 5.5% each year,” said Carol Lynch, president of Sandoz US and head of North America, setting the stage for a session at the Association for Accessible Medicine’s Access! 2019 meeting. “If all approved biosimilars had been marketed in a timely manner, Americans could have saved $4.5 billion.”

The Association for Accessible Medicine’s (AAM's) Access! 2019 Annual Meeting, held February 4-6, 2019 in New Orleans, Louisiana, drew stakeholders from all over the pharmaceutical industry, as well as the political arena. The first panel discussed drug pricing, drug shortages, and consolidation in the marketplace.

As patients are being encouraged to self-manage disease and take an active role in their healthcare, communication with patients about the products that they use is becoming a hot topic among drug makers. 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, stakeholders gathered to discuss new directions in providing digital information to patients.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The second day of the 37th Annual J.P. Morgan Healthcare Conference saw presentations from drug makers Amgen and Sanofi—both of whom produce both innovator products facing biosimilar competition as well as biosimilars of competitors’ products—as well as from Alexion, which is defending its flagship product from advancing biosimilar challengers.