Legal

California has become the first state to implement a policy to produce and distribute its own drug products to help lower costs.

Some acts by companies in the biologics marketplace may go too far in preventing free market activity, according to Markus H. Meier, acting director for the Federal Trade Commission (FTC) Bureau of Competition.

The FDA's Office of Therapeutic Biologics and Biosimilars balances a large number of biosimilar development projects with limited resources and is making progress, says Eva Temkin, acting director of policy.

Courts have allowed biosimilar developers "safe harbor" against infringement suits, but there are limits, attorneys from Goodwin Proctor explain.

Representative Glenn Grothman, R-Wisconsin, says interchangeability for insulins makes sense based on the savings potential and safety record of these agents.

Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.

The Association for Accessible Medicines, which represents generic and biosimilar manufacturers, chose a leader with a research, public relations, and strategic planning background.

Opinion leaders discuss the significance of regulatory changes affecting biosimilar and insulin products.

Two Biogen officials make the case for getting anti–tumor necrosis factor (TNF) biosimilars into wider play.

A Pacific Research Institute economist says that by his scorecard, biosimilars are not supercharging the market the way they ought to be doing .

Opening the door to biosimilar competition starts with breaking down the patent barrier, says Christine Simmon, JD.

If you can’t beat biosimilars, join them, is the mantra; but at Amgen there’s still gold in originator products, according to its latest earnings report.

While Amgen fends off etanercept biosimilar competition in the United States, Pfizer said it is facing a mounting battle against biosimilar competition in European and other markets.

In court filings this week, Genentech and Amgen laid to rest their long-running dispute over the marketing of bevacizumab and trastuzumab biosimilars that challenged Genentech's dominance of the market for those products.

Genentech seeks to block the marketing of Samsung Bioepis’ proposed bevacizumab biosimilar, saying the company infringed multiple patents when submitting an FDA approval application.

In upholding a lower court ruling, a federal circuit court has decided that Amgen gave enough notice prior to launching its bevacizumab biosimilar. The court decision has frustrated an attempt by Genentech to block sales of the product.

Republican opponents of the Affordable Care Act (ACA), led by the state of Texas, fired opening salvos in the Supreme Court case over the landmark law's constitutionality. If the entire law is thrown out, approval for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) would disappear, too.

The judge in the Humira case, while noting that the patents have made it nearly impossible for rivals to gain a foothold, said the suit did not constitute a valid antitrust claim.

Among the briefs filed in defense of the Affordable Care Act and, with it, the Biologics Price Competition and Innovation Act (BPCIA), is one from the Association for Accessible Medicines, which argues the BPCIA is vital to biosimilars market development.

Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies.

Trying to carve back its market share for Neupogen, its filgrastim originator product, Amgen is hoping product exclusivity can be backdated.

European investigators say their analysis of court cases involving innovator monoclonal antibodies suggests secondary patents have generally failed to stop biosimilar competition.

Taking an abundance of time to file a motion to block Kanjinti from coming to market, Genentech unwittingly may have tipped the scales in favor of biosimilar applicants.

Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.

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.

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).

The Supreme Court will hear an appeal by a coalition of 20 mainly Democratic states, which are hoping for a reversal of a Fifth Circuit Court of Appeals ruling that held the Affordable Care Act’s (ACA) individual mandate is unconstitutional and called into question whether the remaining provisions of the law could still stand. However, a decision will not come until after the November 2020 presidential election.

Depending on the outcome, 3 major biosimilar antitrust actions, as well as a related Federal Trade Commission investigation, could significantly change how biologics are priced.

Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade.