Tony Hagen

China is getting the hang of producing biosimilars, and harvest time is on the near horizon, according to a new report.

When providers get used to biosimilars, they tend to prescribe them exclusively, according to a study in The American Journal of Managed Care.

Teva Pharmaceuticals USA has filed suit in an attempt to use the expanded biologics licensure pathway as a way to hold back a potential competitor.

Life under the new biologics pathway will be easier for some drugs than others, notes Stacie L. Ropka, PhD, JD, a patent attorney with Axinn, Veltrop & Harkrider LLP, in Hartford, Connecticut.

The FDA has approved a multidose vial of Samsung Bioepis’ trastuzumab biosimilar Ontruzant, which was first approved as a 150-mg single-dose vial in January 2019 and has yet to reach the US market in either form.

As coronavirus disease 2019 (COVID-19) causes medical systems to bog down from a host of related issues, a UT Health expert said clinical trials likely will be powered down and hospitals will put consideration of newly available agents on hold.

Legal and industry experts ponder whether expanded access to biosimilars is a way around patent thickets that slow the launch of approved biosimilars.

In guidance issued specifically in response to the COVID-19 pandemic, the FDA has advised that clinical trial protocol modifications may be made but must be documented and reported as promptly as possible. The FDA notes that trial participants may be sickened by COVID-19, supplies of investigational drugs may be interrupted, and quarantines and closings may make on-site patient visits impossible.

Schiff Hardin patent attorney Imron T. Aly works with India-based manufacturers of biologics and says supply chain problems are anticipated shortly in the United States, based on FDA inspection policy and sourcing issues.

Teva Pharmaceuticals USA and Celltrion Healthcare have launched the fourth trastuzumab biosimilar, Herzuma, at a 10% discount to the cost of reference product Herceptin.

Supplies of active pharmaceutical ingredients (API) are difficult to track and anticipate owing to limited information that manufacturers are required to provide, an issue that can make it difficult to respond to the COVID-19 pandemic, according to an interview with a Vizient executive.

Seen up close, many patents are not truly strong enough to block biosimilar commercialization, although patents filed after FDA approval of originator products can bar access to modern manufacturing methods, according to Hans Sauer, deputy general counsel and vice president for intellectual property at the Biotechnology Innovation Organization (BIO).

In light of the COVID-19 outbreak, the FDA has suspended foreign inspections of FDA-regulated manufacturing plants and products. Meanwhile, escalating foreign travel restrictions put a damper on growth of the biosimilars industry.

Stakeholder comments at a biosimilars forum staged by the FDA and Federal Trade Commission focused on improving the quality of information being disseminated about biosimilars and the need to make the approval process less burdensome for manufacturers.

The conference was designed to further collaborative efforts between the FDA and the Federal Trade Commission (FTC) and generate public confidence in regulators’ commitment toward fostering a healthy biosimilars marketplace, but the goal is not to put manufacturers of innovator biologics on edge, said Stephen M. Hahn, commissioner of the FDA.

The FDA granted the application for the biosimilar to Avastin a decision date of December 27, 2020.

Katie Verb, director of policy and research for the biopharmaceutical industry group PhRMA, discusses recent policy changes that have increased biosimilar uptake and additional measures that could lead to greater use of biosimilars and savings for CMS and patients.

The US biosimilars market is showing healthy vital signs, said Leah Christl, Amgen’s executive director for global regulatory and research and development policy, in a talk kicking off the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California, while also reassuring the audience that her former FDA colleagues are still champions of their work.

Sarfaraz K. Niazi, PhD, a pharma industry veteran and consultant for biosimilar makers, discusses ins and outs of the approvals process that cause frustration and unnecessary expense.

The orphan drug market could see hefty biosimilar competition, based on revenue potential, and patent struggles need to be resolved before some biosimilars can come to market, according to a speaker reviewing the 2020 pipeline at the Specialty Therapies and Biosimilars Congress.

Biosimilars are starting to gain some traction in the marketplace, according to a speaker reviewing the 2020 pipeline at the Specialty Therapies and Biosimilars Congress.

In a recent presentation at the Specialty Therapies and Biosimilars Congress, the director of pharmacy for Emory Healthcare discussed how they developed a strong in-house specialty pharmacy and cut dependence on outside for-profit specialty pharmacies and managed to strengthen adherence, improve patient outcomes, and reduce costs.

The company has recalled its employees from Wuhan until the outbreak is brought under control, as have many other outside companies and government agencies with workers in the Chinese market affected by the coronavirus.

How does CMS payment policy for Medicare, Medicaid, and 340B hospitals affect biosimilar uptake? A speaker at the recent at the 2020 Specialty Therapies and Biosimilars Congress explained.

Panelists at the 2020 Specialty Therapies and Biosimilars Congress discussed the strategies needed to get biosimilars to market and overcome obstacles by originator product manufacturers.

Molly Burich, MS, director of public policy for biosimilars and pipeline at the pharmaceutical giant Boehringer Ingelheim, discussed the International Price Index proposal Thursday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

In a wide-ranging state-of-the-industry talk, the clinical operations manager for Blue Cross Blue Shield of Michigan discussed pending legislation, electronic prior authorization (ePA), and biosimilar uptake, among other prominent issues Wednesday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

It’s important to keep in mind the successive patents that can be filed to keep an original product in a position of market dominance, and drug descriptions in biologic license applications can be written cleverly to achieve this aim, according to a panelist speaking at the Specialty Therapies and Biosimilars Conference, happening January 22-24, 2020, in Miami, Florida.

The company's announcement of an aggressive launch calendar at the JP Morgan Healthcare Conference in San Francisco last week was followed by Celltrion’s announcement this week that it plans to open a large biologics manufacturing plant in Wuhan, China.

Gilead Science’s new chairman and chief executive officer outlined a growth plan this week at the J.P. Morgan Healthcare Conference in San Francisco, California.