Insights+ Key Biosimilars Events of November 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 November, Bio-Thera Solutions reported the NMPA's acceptance of MAA for BAT1806 (biosimilar, tocilizumab) to treat rheumatoid arthritis, Prime Therapeutics listed interchangeable insulin biosimilar Semglee on its national formularies. Our team at PharmaShots has summarized 8 key events of the biosimilar space of November 2021

Published: Nov 02, 2021

Product: Pegfilgrastim Biosimilar

Fresenius Kabi discusses the US FDA’s review about the prospects of pegfilgrastim biosimilar product and the commercialization of the product
The company also plans for MSB11456 (biosimilar, tocilizumab) based on the recent positive results which are used for the treatment of RA referencing Actemra
The company is awaiting the completion of the US FDA’s inspection to enable the completion of the Stimufend application review. The company has scaled the pegfilgrastim biosimilars in the EU

Published: Nov 03, 2021

Product: Semglee

Viatris’ biosimilar Semglee injection and Insulin injection will be listed on its national formularies as part of the pharmacy benefit. The biosimilar is co-developed with Biocon
The decision follows the US FDA’s approval of the first interchangeable biosimilar insulin product through the interchangeable pathway. Both products will be available in pen and vial presentations and are interchangeable for Lantus
The company has launched MedDrive medical drug management solutions to focus on drug savings strategies through greater biosimilar drug adoption while other elements of MedDrive include benefit designs, enhancements to predictive data analytics, medical sourcing opportunities, and consultation services

Published: Nov 04, 2021

Product: Abrilada (biosimilar, adalimumab)

The company plans to file for an interchangeable biosimilar of adalimumab in the US and is expected to launch Humira biosimilar Abrilada (adalimumab-afzb) in July 2023
Additionally, the company also plans to launch Cyltezo, an adalimumab biosimilar in 2023 & has received interchangeable status from the US FDA
The company has multiple oncology biosimilars and supportive oncology biosimilars & also has Retracrit (epoetin alfa), Nivestym (filgrastim), and Nyvepria (pegfilgrastim) that allows the patients to recover from blood-cell depletion following CT

Published: Nov 08, 2021

Product: Amjevita (biosimilar, adalimumab)

Amgen plans to seek interchangeable status for its adalimumab biosimilar Amjevita. The company plans to launch Amjevita (biosimilar, adalimumab) in 2023 in the US
Amgen reported that patients are currently being enrolled in P-III studies to support interchangeability designation in the US for biosimilars of Amjevita (adalimumab) and ABP 654 (ustekinumab)
The company is expected the P-III results shortly for biosimilar Stelara (ustekinumab) to treat PsO and PsA while Eylea (aflibercept) for macular degeneration and Soliris (eculizumab) for PNH and aHUS

Published: Nov 11, 2021

Product: N/A

Merck spinoff Organon & showed a slight decline in women’s health medications but growth in biosimilar sales in Q3’21. Organon’s lead pipeline product is used to treat endometriosis,
Additionally, Novartis also consider the spinoff of its biosimilar division, Sandoz as a standalone company. Sandoz currently has eight biosimilars launched globally and 15 more in the pipeline
Novartis has reported the start of a strategic review of the Sandoz division. The review will explore all options for Sandoz from retaining the business to separation. The review will stop at the end of 2022

Published: Nov 16, 2021

Product: BAT1806 (biosimilar, tocilizumab)

The NMPA has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra (tocilizumab) for the treatment of patients with arthritis
In June 2021, the results from the P-III study of BAT1806 showed equivalent efficacy and comparable safety to the originator in patients with moderate-to-severe RA
Tocilizumab is an immunosuppressive drug that acts on the receptor of the inflammatory cytokine receptor, IL-6 & is used for the treatment of inflammatory conditions including RA and systemic JIA. In June' 2021, the US FDA has granted a EUA for the treatment of COVID-19 in the US & is sold under the brand name Actemra

Published: Nov 16, 2021

Product: Semglee

The companies launch Semglee and Insulin Glargine as interchangeable biosimilars products to improve patients' access with type 1 & 2 diabetes. Biocon and Viatris have co-developed both biosimilars products
Both biosimilars products are available in a vial and prefilled pen presentations & will allow pharmacy level substitution for the reference product, Lantus across the US. Semglee is expected to be phased out at the end of 2021
Viatris has established multiple options for patients including a patient assistance program to provide free products to eligible patients with financial need, Copay program for eligible commercially-insured patients along with other programs

Published: Nov 21, 2021

Product: Sintilimab + Byvasda (biosimilar, bevacizumab)

The P-III ORIENT-31 study evaluates sintilimab with/out Byvasda (bevacizumab biosimilar inj.) + CT vs CT alone in a ratio (1:1:1) in patients with EGFR-mutated LA or metastatic nsq.NSCLC who have progressed following EGFR TKI treatment

The results showed an improvement in PFS at 1st interim analysis in ITT population, m-PFS (6.9mos. & 4.3mos.) with numerical benefit & 2EPs showed an improvement in ORR & DoR, PFS data was immature. The safety profile was consistent with previously reported studies of sintilimab & Byvasda & no new safety signals were observed
The company plans to file the sNDA to NMPA shortly & has 2 regulatory submissions which are accepted for review in China for sintilimab monothx. to treat ESCC

Source: ALPCO

Related Post: Insights+ Key Biosimilars Events of October 2021