Business

Revance Gives Mylan Additional Time to Decide on Botox Biosimilar Development

August 28th 2019

By Kelly Davio

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).

Ahead of US Biosimilar Etanercept Competition, Amgen Acquires Apremilast

August 27th 2019

By The Center for Biosimilars Staff

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.

Dr. Reddy's Launches Bevacizumab Biosimilar in India, Eyes Emerging Markets Next

August 24th 2019

By The Center for Biosimilars Staff

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.”

Employers Could Reap Substantial Savings Through Biosimilars, but Not Without Targeted Effort

August 23rd 2019

By Kelly Davio

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 Top 5 Biosimilars Articles for the Week of August 19

August 23rd 2019

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

Eye on Pharma: Biocon's Insulin Facility Earns GMP Certification

August 22nd 2019

By The Center for Biosimilars Staff

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.

As Device Design Becomes a Way to Differentiate Biosimilars, What Do Patients Prefer?

August 21st 2019

By Kelly Davio

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

Gedeon Richter Launches Teriparatide Biosimilar in Europe

August 20th 2019

By Kelly Davio

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.

Court of Appeals for the Federal Circuit Declines to Halt Sales of Biosimilar Bevacizumab

August 19th 2019

By Kelly Davio

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.

AbbVie Gains FDA Approval for Upadacitinib, Its Successor to Humira

August 19th 2019

By Kelly Davio

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.