Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are highly similar to existing biological products and are designed to be as effective and safe as the brand name drugs, offer the potential to provide
Aydin Harston combines his love for science and technology with legal expertise to advocate for his clients in all matters necessary to grow, protect, and defend their businesses. With a Ph.D. in biochemistry and numerous scientific and legal publications, Aydin seeks to produce creative and effective approaches to achieve his clients' goals as efficiently as possible.
The United States Patent and Trademark Office (USPTO) issued updated guidance on the duty of candor and duty to disclose in relation to submissions made to other government agencies, particularly the Food and Drug Administration (FDA). The Notice did not constitute new rule making and instead aims to clarify the obligations of patent applicants and…
On August 2, 2022, Coherus BioSciences announced that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all five indications, meeting the FDA’s rigorous standards to the reference product, including safety, efficacy, and quality. Coherus plans to launch CIMERLI™ in early October 2022.…
- FDA and EMA both approve additional biosimilar versions of Humira® (adalimumab).
- FDA also approves its third biosimilar version of Neupogen® (filgrastim).
- EMA has not approved any new biosimilars in 2022, but has recommended approval of teriparatide biosimilar Sondelbay and the pegfilgrastim biosimilar Stimufend.
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a…
Updated November 15, 2021
- FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab).
- FDA has approved only two biosimilars in 2021 after only approving three in 2020.
- EMA approves four more Avastin® (bevacizumab) biosimilars, bringing the total number of approved bevacizumab approvals to nine, but also withdraws approval of two of bevacizumab and
On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira® (adalimumab). We previously discussed Boehringer Ingelheim’s Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”). The…
Updated March 8, 2021
- FDA has not approved any biosimilars in 2021 after only approving three in 2020.
- EMA approves second Novolog® (insulin aspartate), fifth Avastin® (bevacizumab), eighth Neulasta® (pegfilgrastim), and twelfth Humira® (adalimumab) biosimilars, and withdraws approval of an adalimumab biosimilar and a pegfilgrastim biosimilar.
- Given the increasing number of approved biosimilars in Europe,
Updated October 12, 2020
- FDA has only approved two biosimilars in 2020.
- No biosimilars have launched in the U.S. since April 2020.
- EMA approves first Novolog® (insulin aspartate), third and fourth Avastin® (bevacizumab), and sixth Herceptin® (trastuzumab) biosimilars.
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs…
- FDA has not approved any biosimilars in 2020.
- Two Herceptin® (trastuzumab) biosimilars launch in the U.S. in Q1 2020.
- EMA approves third Enbrel® (etanercept), eleventh Humira® (adalimumab), seventh Rituxan® (rituximab), and second Humalog® (insulin lispro) biosimilars.
- FDA has redefined “Biologic Products” to open new pathways for biosimilar and interchangeable approvals of proteins including insulin.
- Since November 2019, biosimilar versions of pegfilgrastim, rituximab, bevacizumab, and trastuzumab have launched in the United States.
- FDA approved fifth Humira® (adalimumab) biosimilar, but it will not launch until 2023.
- FDA approved third Neulasta® (pegfilgrastim) biosimilar and all three have launched.
- FDA approved fourth Remicade® (infliximab) biosimilar.
As pharmaceutical drug costs attract increasing media attention…