Business

Genentech has reached a memorandum of understanding with JHL Biotech in its civil lawsuit related to the theft of Genentech’s trade secrets.

The Center for Biosimilars® recaps the top stories for the week of September 2, 2019.

More than 20 groups, representing patients, employers, and others, are asking HHS to end cost-sharing for Medicare Part B patients when a provider administers a biosimilar rather than a reference biologic.

Amitabh Chandra, PhD, Ethel Zimmerman Wiener professor of public policy and director of health policy research at the Harvard Kennedy School of Government, says that while price regulation is not impossible, “It’s very, very hard to do. Given that it’s hard to do, do we need to do it?”

The pharmaceutical industry hit bottom in public opinion, ranking last in Gallup’s list of 25 industries, according to a new annual poll.

Celltrion announced this week that it will contract with Swiss biologics maker Lonza to manufacture biosimilar infliximab CT-P13, sold as Remsima and Inflectra, in Singapore.

England’s National Health Service (NHS) says that it has saved £110 million (US $134 million) by implementing its policy to use the best-value adalimumab after the brand-name Humira lost European patent protection in October 2018.

Last week, the Patent Trial and Appeal Board (PTAB) instituted 3 inter partes review proceedings concerning patents on Alexion’s brand-name eculizumab, Soliris, a complement inhibitor that treats rare diseases. Amgen is the petitioner in all 3 cases, which were filed in February of this year.

Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second Complete Response Letter (CRL) for their follow-on insulin glargine product referencing Lantus.

Sandoz, a Novartis division, announced today that it has entered into a global commercialization agreement with Poland-based Polpharma Biologics for a proposed natalizumab biosimilar referencing Biogen’s Tysabri. Natalizumab is a disease-modifying therapy used to treat relapsing-remitting multiple sclerosis (MS) as well as Crohn disease.

As medicines become more numerous and often more expensive, healthcare professionals seek new ways to understand which treatments are most likely to yield the best outcomes at sustainable costs.

In the oncology realm, August 2019’s biggest business development was the forward momentum of Amgen’s 2 newly debuted oncology biosimilars, and perhaps the biggest news in the biosimilar space from the inflammatory disease perspective also involved Amgen and its involvement in a long-running patent dispute.

The Center for Biosimilars® recaps the top stories for the week of August 26, 2019.

Amgen, maker of the brand-name pegfilgrastim (Neulasta), and Mylan, which partnered with Biocon to develop a biosimilar (Fulphila), have entered a joint status report in the District Court for the Western District of Pennsylvania.

This week saw a pair of developments for patients with neuromyelitis optica spectrum disorder (NMOSD), a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal.

In a filing with the US Securities and Exchange Commission this month, Silicon Valley-based biotech company Revance Therapeutics said that it has entered into an amendment to a Collaboration and License Agreement with Mylan; the amendment extends the period of time Mylan has to decide whether to continue to develop and commercialize a biosimilar of Allergan’s onabotulinumtoxinA (Botox).

Amgen announced yesterday that it will acquire apremilast (Otezla) from Celgene. The small-molecule drug, which inhibits phosphodiesterase 4, specific for cyclic adenosine monophosphate, is an orally administered therapy for patients with psoriatic arthritis and patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

In 2018, Dr. Reddy’s indicated that it expected to initiate clinical studies for the bevacizumab biosimilar to facilitate EU and US regulatory approval, but this week, a company representative told The Center for Biosimilars® in an email that, “currently, we are gearing up for filings in emerging markets for Versavo.”

A new report from Matrix Global Advisors and the National Business Group on Health, sponsored by Boehringer Ingelheim, shows that employers could see substantial savings from biosimilars, but those savings won’t come without a concerted effort to encourage biosimilar use.

The Center for Biosimilars® recaps the top stories for the week of August 19, 2019.

Biocon has gained a certificate of good manufacturing practice (GMP) from the European Medicines Agency’s Irish inspection authority for its Malaysian manufacturing site where it produces its insulin glargine biosimilar, Semglee, referencing Lantus.

Along with innovations in design comes the question of patients’ willingness to pay for features that differentiate self-injection devices from one another.

Hungary-based Gedeon Richter announced today that it has launched a biosimilar teriparatide, Terrosa, in Europe. The drug, referencing Eli Lilly’s Forsteo (sold as Forteo in the United States), is used to treat osteoporosis. The product will also be sold under the brand name Movimya by the company's partner, Stada.

In a one-page order filed last week, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal.

Upadacitinib is expected to help AbbVie continue to lead in the immunology market after biosimilar competition emerges for adalimumab in 2023. The approval for the treatment of RA is one of 6 indications that AbbVie’s chief executive officer, Richard Gonzalez, said in a 2018 presentation that the company expects to have approved and launched by 2022.

With rising concern over rising drug prices, policymakers have sought a better understanding of the roles of pharmacy benefit managers (PBMs) in the drug supply chain and plans' and PBMs' efforts to manage Part D drug spending and use.

Samsung Bioepis has begun recruiting patients with paroxysmal nocturnal hemoglobinuria (PNH) in India for a phase 3 clinical study of its proposed eculizumab biosimilar, SB12, referencing Soliris.

The Center for Biosimilars® recaps the top stories for the week of August 12, 2019.

In its August 2019 network bulletin, UnitedHealthcare indicated that, beginning October 1, 2019, biosimilar bevacizumab (Mvasi) and biosimilar trastuzumab (Kanjinti), both made by Amgen, will be preferred products for commercial and community plans.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.