Insights+ Key Biosimilars Events of October 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of October, Bio-Thera expanded its partnership with Pharmapark to commercialize BAT2206 (biosimilar, ustekinumab) in Russia and other CIS countries, Boehringer Ingelheim's Cyltezo (biosimilar, adalimumab) received the US FDA's sBLA approval as the 1st interchangeable biosimilar for multiple chronic inflammatory diseases. Our team at PharmaShots has summarized 8 key events of the biosimilar space of October 2021

Published: Oct 1, 2021

Product: CHS-201 (biosimilar, ranibizumab)

The US FDA has accepted the BLA under the 351(k) for CHS-201 (biosimilar, ranibizumab) with an anticipated BsUFA date is Aug 02, 2022
If approved, the company plans to launch the Lucentis biosimilar in the US in H2'22
Additionally, Coherus' biosimilar portfolio includes Udenyca which has launched in the US in Jan'19 while CHS-1420 (biosimilar, adalimumab) is currently under FDA's review with anticipated PDUFA date on Dec'21 & CHS-305 (biosimilar, bevacizumab) is currently being evaluated in PK study to support a BLA submission in 2022

Published: Oct 5, 2021

Product: CHS-201 (biosimilar, ranibizumab)

The COLUMBUS-AMD trial evaluates the clinical efficacy, safety & immunogenicity of CHS-201 (q4w for up to 48wks.) vs Lucentis in a ratio (1:1) in 477 patients with newly diagnosed subfoveal nAMD
The results showed a mean BCVA improvement from baseline @8wks. with an equal median change in both treatment groups, patients experienced similar reductions in FCP & FCS retinal thickness along with total lesion area. The therapy also showed a similar reduction in the proportion of patients with active CNV leakage & an increase in the fluid-free macula
The FDA has accepted the BLA for CHS-201's review with an anticipated PDUFA date is Aug 2, 2022. If approved, the company plans to launch CHS-201 in the US in H2'22

Published: Oct 4, 2021

Product: BQ201's (biosimilar, ranibizumab)

The US FDA has issued a notification to Polpharma Biologics for the acceptance of BQ201's (biosimilar, ranibizumab) BLA to treat wet AMD with an anticipated PDUFA date in Aug'22
The launch of biosimilar ranibizumab may increase market competition, reduce cost & expand patient access with proven analytical & clinical similarity to Lucentis
Coherus will exclusively commercialize BQ201 in the US, following the FDA's approval. Bioeq's proposed ranibizumab biosimilar BQ201 (formerly FYB201) has been originally licensed from Formycon AG

Published: Oct 4, 2021

Product: FYB201 (biosimilar, ranibizumab)

The US FDA has accepted the BLA for FYB201, a biosimilar referencing Lucentis for review and assigned a target action date for the application for Aug'2022
Following the approval, Coherus will commercialize FYB201 in the US whereas Formycon will participate economically in US sales through its interest in royalties paid by Coherus to Bioeq
Lucentis is used in the treatment of neovascular (wet) macular degeneration and acts by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina

Published: Oct 18, 2021

Product: BAT2206 (biosimilar, ustekinumab)

Pharmapark to get exclusive rights to commercialize the therapy with a status of a local product & will be responsible for filing the report in Russia and other CIS countries
The agreement will utilize Pharmapark's sales and marketing capabilities for the ustekinumab biosimilar program in Russia & other CIS countries. Bio-Thera will lead the development, and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China
Bio-Thera's BAT2206 has completed a P-I study and is currently being evaluated in a P-III clinical study including patients from China, Russia, and other countries & plans to file for regulatory approval with the NMPA, EMA & FDA

Published: Oct 18, 2021

Product: Cyltezo (biosimilar, adalimumab)

The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases
The study showed that Cyltezo was equivalent to Humira & demonstrated that switching several times b/w Cyltezo and Humira resulted in no clinical differences in PK, efficacy, immunogenicity, and safety b/w both the groups. The results were presented at the AAD 2021 conference
Currently, Cyltezo is not commercially available in the US, its commercial license will begin on Jul 01, 2023. The FDA originally approved Cyltezo in 2017 to treat multiple chronic inflammatory diseases

Published: Oct 20, 2021

Product: Interchangeable Insulin Biosimilar

Viatris interchangeable biosimilar Semglee (insulin glargine-yfgn) injection will be added to Express Scripts as a preferred insulin brand on its NPF for diabetic patients in the US
Biocon and Viatris have jointly developed Semglee. Additionally, Viatris will commercialize two interchangeable biosimilar insulin glargine injections at the end of 2021 i.e., Semglee & Insulin to improve patients' access to diabetes. Additionally, formulary coverage of Semglee on its NPF initiates in Jan'22
Both products will be available in pen and vial presentations and are interchangeable for the reference brand, Lantus

Published: Oct 27, 2021

Product: BCD-021 (biosimilar, bevacizumab)

The P-III study evaluates the efficacy, safety & immunogenicity of BCD-021 (q3w for 6 cycles) vs Avastin + paclitaxel & carboplatin in 357 patients with stage IIIB or IV nonsq. NSCLC across Russia, Belarus, Ukraine & India
The results showed an equivalent efficacy when assessed as risk difference & risk ratio; ORR (34.6% & 33.8%) while 341 patients had 1 CT scan after initiation of treatment; patients with SD, CR, or PR @18wks. were offered BCD-021 until disease progression, death, or unacceptable toxicity
Additionally, baseline characteristics were balanced b/w BCD-021 and reference bevacizumab. The biosimilars will broaden the access of various populations to bevacizumab therapy

Source: Biovoice News

Related Post: Insights+ Key Biosimilars Events of September 2021