Regulatory

The Center for Biosimilars® recaps the top news for the week of December 3, 2018.

In the United States, Amgen has 57 patents on Enbrel, whereas in Europe it has 20, and in Japan it has 18.

Last month, the European Parliament’s Health Committee introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers. On December 4, 2018, the committee voted in favor of the amendments.

In revised draft guidance published in October 2018, the FDA announced its intention to crack down on citizen petitions that seek to delay competition from generic or biosimilar drugs. Now, in a comment letter, the Federal Trade Commission (FTC) has said that it stands ready to work with the FDA on curtailing abusive petitions.

The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA to clarify appropriate sponsor communications about biosimilars.

The Center for Biosimilars® recaps the top news for the week of November 26, 2018.

JCR Pharmaceuticals announced yesterday that it has launched its biosimilar agalsidase beta product, referencing Fabrazyme, in Japan for the treatment of Fabry disease. JCR developed the drug in partnership with Amicus Therapeutics and GlaxoSmithKline.

The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs).

Sandoz announced today that the European Commission has granted a marketing authorization for its pegfilgrastim biosimilar, Ziextenzo, referencing Neulasta.

The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.

Mylan and Biocon jointly announced earlier this month that their biosimilar insulin glargine, sold as Semglee and referencing Lantus, has launched in the United Kingdom.

The Center for Biosimilars® recaps the top news for the week of November 19, 2018.

The FDA recently announced that it approved a record-breaking number of generic drugs in October 2018.

This month, Novartis submitted a letter to the FDA in support of a citizen petition that Pfizer filed in August.

Samsung BioLogics, parent company of the biosimilar development business Samsung Bioepis, has been fined by the Republic of Korea’s financial regulatory body, The Securities and Futures Commission, after the commission ruled that Samsung had committed fraud.

The Center for Biosimilars® recaps the top news for the week of November 12, 2018.

Innovent Biologics, a China-based biopharmaceutical company, announced that its new drug application for its proposed adalimumab biosimilar IBI303, referencing Humira, was accepted by the National Medical Products Administration.

Genentech says that the biosimilar company benefited from its proprietary information, and a hearing is scheduled for December 13, 2018.

The Center for Biosimilars® recaps the top news for the week of November 5, 2018.

Allergan’s dry-eye drug, Restasis, has been the subject of complex legal wrangling involving the transfer of patents that could next extend to the Supreme Court of the United States. Now, in a separate twist in the story of generic competition for the cyclosporine ophthalmic emulsion, generic developer Teva has sued the FDA in the United States district court for the District of Columbia over Teva’s status as the first filer of a generic version of the drug.

Notably, Oncobiologics revealed that it is developing the bevacizumab product as an innovator therapy, and it will not use the biosimilar pathway for eventual approval.

Republic of Korea-based Celltrion has won a court decision that declared patents on Roche’s Herceptin invalid in Japan.

Sandoz announced on Friday that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013.

The Center for Biosimilars® recaps the top news for the week of October 29, 2018.

After previous US regulatory setbacks, Coherus Biosciences has gained FDA approval for its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv).

According to the United States Attorney's Office, Xanthe Lam, a principal scientist at the Roche Holding AG unit from 1986 until 2017, conspired with her husband and fellow former employee Allen Lam, and John Chan, another former Genentech employee, to steal trade secrets over the course of 5 years related to the biopharmaceutical dornase alfa (Pulmozyme) and some of Roche’s top-selling cancer drugs: rituximab (Rituxan), trastuzumab (Herceptin), and bevacizumab (Avastin).

The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz).

Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.

The Center for Biosimilars® recaps the top news for the week of October 22, 2018.

While it is indeed the case that the current administration has made drug pricing and biosimilars a priority, and while the Biosimilar Action Plan was hailed as a major step forward for biosimilars in the United States, “It’s not the only plan that’s going to exist,” said the FDA's Leah Christl, PhD.