Regulatory

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.

How Prepared Is the United States for the Transition of Insulins to Regulation as Biologics?

August 20th 2019

By Kelly Davio

While drug makers who sell insulin in the United States have had the past decade to prepare for the transition, stakeholders within the diabetes community must grapple with the potential impacts that this regulatory change could have.

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.

Eye on Pharma: FDA Gives Green Light to Aflibercept in Prefilled Syringe

August 14th 2019

By The Center for Biosimilars Staff

Regeneron’s aflibercept (Eylea) has been approved by the FDA for a prefilled syringe (PFS) presentation. The 2-mg, single-dose, PFS will offer the greater ease of use less preparation than the vial presentation of the drug used to treat a range of eye disorders.

Time to Replace the Totality of the Evidence Approach to Biosimilars?

August 13th 2019

By Kelly Davio

Instead of the “totality of the evidence” approach to biosimilars, authors of a new paper propose a “confirmation of sufficient likeness” paradigm.

The Top 5 Biosimilars Articles for the Week of August 5

August 9th 2019

The Center for Biosimilars® recaps the top stories for the week of August 5, 2019.

IGBA's Trade Principles Address Regulatory Convergence and Intellectual Property Concerns

August 7th 2019

By The Center for Biosimilars Staff

The International Generic and Biosimilars Medicines Association (IGBA), which represents generic and biosimilar medicines associations worldwide, recently released its report on how trade agreements can foster generic and biosimilar medicines and improve patient access to care.

The Top 5 Biosimilars Articles for the Week of July 29

August 2nd 2019

The Center for Biosimilars® recaps the top stories for the week of July 29, 2019.

HHS Announces Plan to Allow Importation of Foreign Drugs, Potentially Including Insulin

July 31st 2019

By The Center for Biosimilars Staff

The first pathway for importation outlined in the plan would rely on a notice of proposed rulemaking to authorize importation of drugs from Canada. The second pathway would allow manufacturers to import versions of FDA-approved drugs that are sold in other countries.

Biosimilar Regulatory Roundup: July 2019

July 31st 2019

By Kelly Davio

July 2019 was a busy month for biosimilars on the regulatory front; not only did the FDA approve new products, but numerous policy proposals with a potential impact on biosimilar regulation were put forward by law makers.