News

As Congress prepares to begin its new term, newly elected lawmakers will convene to tackle issues such as the high cost of drugs. As they prepare to address these policy challenges, a new analysis shows that several key congressional leaders have received major contributions from the pharmaceutical industry.

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.

Biologic drugs can effectively treat inflammatory bowel disease (IBD), but the cost of these products can be prohibitive. Biosimilars such as CT-P13 (Remsima, Inflectra), an infliximab biosimilar referencing Remicade, have the potential to drive down treatment costs and enhance access to biologics for the patients who need them.

2018 was an eventful year for the biosimilars marketplace. We asked experts from across stakeholder groups—and from the United States and abroad—what they felt were the most notable moments in biosimilars during 2018, and what they hope the new year holds for this developing industry.

A number of notable guests meet The Center for Biosimilars® in 2018 to discuss important developments in this emerging field. Here are the most-watched interviews of the year.

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.

The Center for Biosimilars® recaps the top news of 2018.

On the heels of the FDA approval of Celltrion’s rituximab biosimilar Truxima in November 2018, December saw the publication of a variety of new data on biosimilars used in hematology.

There were a variety of developments in the biosimilars space in 2018, and our expert contributors responded to those changes with in-depth insights that reflected the complexity of the biosimilars landscape.

Despite the fact that the World Health Organization classifies insulin as an essential medicine that should be available at all times at a price that patients can afford, US insulin prices have continued to climb in recent years.

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.

Germ cell tumors are common malignancies, and chemotherapy with a regimen of bleomycin, etoposide, and cisplatin (BEP) has improved the prognosis for patients with these tumors. However, BEP involves significant myelosuppression, and the safety of pegfilgrastim for the prevention of febrile neutropenia related to myelosuppression has not been well investigated in patients with this tumor type.

While Kawasaki disease (KD) typically affects children, it can, in rare cases, affect adults, leading to coronary artery abnormalities and acquired heart disease. Given that the disease is rare in adults and that its etiology is not fully understood, diagnosis and treatment of KD in adults can be challenging.

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 systematic review of the literature reported on randomized controlled trials and nonrandomized studies on the use of granulocyte colony-stimulating factor therapies (G-CSFs) to reduce the incidence of febrile neutropenia, and found that short- and long-acting therapies, when dosed according to guidelines, have little difference in their efficacy.

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.

This month, Korean biosimilar developer Chong Kun Dang announced that it has received approval to sell its biosimilar, CKD-11101, referencing darbepoetin alfa (Aranesp). CKD-11101 is the first biosimilar of the erythropoiesis-stimulating protein to be authorized in a highly regulated nation.

Drugs that treat rare diseases are granted various incentives under the Orphan Drug Act of 1983 if they meet criteria related to the size of the rare disease population (under 200,000 people) that can be effectively treated by the drug in question. The Government Accountability Office (GAO) recently issued a report that finds serious deficiencies with the ways in which the Orphan Drug Act is administered by the FDA.

During the European Society for Medical Oncology’s Asia 2018 annual meeting, held in Singapore from November 23 to November 25, a research team presented an update on the clinical program for HLX02, a proposed trastuzumab biosimilar referencing Herceptin. The proposed biosimilar is being developed by the Chinese firm Shanghai Henlius Biotech.

This week, Japan-based Fuji Pharma announced that it has acquired a 4.2% stake in Alvotech, a biopharmaceutical company focused on the manufacturing of biosimilars, for roughly $50 million.

The Center for Biosimilars® recaps the top news for the week of December 17, 2018.

Researchers presented results from a simulation analysis that looked to identify the potential reduction in Medicare beneficiaries’ out-of-pocket costs through the use of biosimilar filgrastim-sndz (Zarxio, Sandoz) over the reference filgrastim at the 2018 San Antonio Breast Cancer Symposium held December 4-8, 2018, in San Antonio, Texas.

During last month’s European Society for Medical Oncology Asia 2018 annual meeting, held in Singapore from November 23 to November 25, researchers presented data demonstrating the biosimilarity of QL1101 with reference bevacizumab (Avastin).

CreakyJoints, a patient organization that is part of the Global Healthy Living Foundation (GHLF), has released the first edition of its patient guide to biosimilar medicines.

Under terms of the agreement, Cipla will have exclusive rights to distribute and market Prestige’s trastuzumab biosimilar (HD201) in selected emerging markets.

Sandoz has entered into an agreement with Chinese drug maker Gan and Lee to commercialize biosimilar insulins to treat patients with type 1 and type 2 diabetes.

Senator Elizabeth Warren, D-Massachusetts, has introduced a bill in the Senate that would create an Office of Drug Manufacturing within HHS. Simultaneously, Representative Jan Schakowsky, D-Illinois, introduced an identical bill in the House of Representatives.

While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.

Mylan and Biocon have received final approval from the European Commission to market their trastuzumab biosimilar, Ogivri, referencing Herceptin.

Last week, Insurer Cigna and pharmacy benefit manager (PBM) Express Scripts overcame 2 hurdles to completing their $67 billion merger as New York and California insurance regulators signed off on the deal.