Samantha DiGrande

After the Association for Accessible Medicines’ (AAM’s) Access! 2019 annual meeting came to a close last week, The Center for Biosimilars® spoke with Christine Simmon, senior vice president of policy and strategic alliances, AAM, and executive director, AAM’s Biosimilars Council, to get her take on some of the outcomes of the meeting.

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.

Finnish-based biosimilar developer, Paras Biopharmaceuticals Finland Oy, said this week that it is ready to begin testing its potential romiplostim biosimilar in clinical trials.

Innovent Biologics, a China-based biopharmaceutical company, recently submitted a New Drug Application for its proposed bevacizumab biosimilar, IBI-305, referencing Avastin, to the Chinese regulatory agency, the National Medical Products Administration.

A specific focus of the European Commission and European Parliament is to investigate the effect potential mergers and acquisitions (M&As) will have on the state of the market.

In the past year, Biocon received marketing approvals in the European Union for both its biosimilar pegfilgrastim (sold as Fulphila) and its biosimilar trastuzumab (sold as Ogivri), which were co-developed in a partnership with Mylan.

A South Korean court ruled this week that penalties imposed against Samsung BioLogics, parent company of biosimilar developer Samsung Bioepis, by the Financial Services Commission (FSC) for allegedly committing fraud have been suspended.

The study investigators noted that the number of individual case safety reports related to infliximab biosimilars increased directly after the marketing availability of the medicines in Italy, which can be interpreted as a result of more patients having access to infliximab therapy.

The FDA has approved Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer and HER2 overexpressing gastric cancer.

Researchers recently sought to evaluate the efficacy and safety of infliximab biosimilar CT-P13 in the treatment of Takayasu arteritis (TAK), a granulomatous inflammatory vasculitis that affects the aorta and can cause aneurysms to form. Some patients with TAK benefit from corticosteroids or second-line, small-molecule immunosuppressive agents, but there is a demand for more effective therapeutic options.

Senators Amy Klobuchar (D-Minnesota) and Chuck Grassley (R-Iowa) recently reintroduced bipartisan legislation aimed at bringing down prescription drug costs.

Bio-Thera announced yesterday that it has partnered with Cipla Limited in a licensing agreement for its potential bevacizumab biosimilar, BAT1706, referenced on Avastin.

Last week, Senator Bernie Sanders, I-Vermont, and Representative Elijah Cummings, D-Maryland, introduced legislation comprising 3 bills to curb the cost of prescription drugs.

Swedish biotechnology company Xbrane Biopharma recently announced that it has submitted its first national Clinical Trial Application to the FDA seeking permission to begin the Xplore trial.

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.

Presenters during the 37th annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California provided an overview about what potential investors can expect to see from their companies’ pharmaceutical pipelines over the next fiscal year.

The Community Oncology Alliance (COA) recently formed a standing Biosimilars Committee for which The Center for Biosimilars® advisory board member, Kashyap Patel, MD, a practicing medical oncologist at Carolina Blood and Cancer Care in South Carolina, was named chair alongside co-chairs immediate past president of COA, Jeff Vacirca MD, FACP, and Michael Diaz, MD, incoming COA president.

In October 2018, HHS Secretary Alex Azar proposed requiring drug companies to include the list price of a drug paid for by Medicare or Medicaid in direct-to-consumer (DTC) television advertising. Since the rule was announced, it has drawn feedback from stakeholders across the spectrum. The proposal, for which a comment period recently closed, received more than 140 comments on the Federal Register from payers, providers, patient advocacy groups, and others, varying in support of the proposal to raising concerns.

After several pharmaceutical companies agreed to halt drug price increases in 2018 after receiving pressure from the Trump administration, the industry has kicked off 2019 with price increases on more than 250 prescription drugs.

The American College of Rheumatology (ACR) is apprehensive that “without substantial changes, the demonstration program could disrupt patient access to care, worsen the rheumatology workforce shortage, and exacerbate geographic disparities in access to medical care.”

Hu5F9, an immune checkpoint inhibitor blocking CD47, has showed promise in working together with rituximab to eliminate non-Hodgkin lymphoma cells. A recent study looked to evaluate the drug in combination with rituximab in a clinical setting.

Data on the risk of tuberculosis (TB) reactivation with infliximab therapy in patients with inflammatory bowel disease (IBD) who are from countries where TB is particularly prevalent, such as India, remains limited. A recent study sought to evaluate the rate of tubercular reactivation with infliximab in a cohort of patients with IBD.

Vedolizumab is approved by the FDA for the treatment of moderate to severe Crohn disease or ulcerative colitis, both forms of inflammatory bowel disease (IBD), who have had an inadequate response or loss of response to immunomodulators, tumor necrosis factor inhibitors, or corticosteroid therapy.

Over the course of 2018, The Center for Biosimilars® provided coverage of conferences in the United States and abroad. Here is a look at our top 5 conference coverage articles from 2018.

A recent study evaluated the impact of adding bevacizumab to chemotherapy treatment for patients who were newly diagnosed with ovarian cancer. The results, published in Gynecologic Oncology, found that while the addition of bevacizumab greatly improved progression-free survival (PFS), it did not improve overall survival.

A recent study sought to investigate the overall survival (OS) advantage of the addition of trastuzumab to chemotherapy for patients with human epidermal growth factor 2-positive early breast cancer.