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Celltrion
NEWS

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) Designation was backed by P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was…
April 15, 2025

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Viewpoints_Uwe Gudat
VIEWPOINTS

Biocon Biologics at EADV Congress 2024: Uwe Gudat in a Stimulating Dialogue Exchange with PharmaShots

Shots:  At the European Academy of Dermatology and Venereology (EADV) 2024 Congress, Biocon Biologics presented results from two pivotal P-III clinical studies. These studies supported the interchangeability between Humira and adalimumab-fkjp, as well as the biosimilarity between Bmab 1200 and Stelara for the treatment of patients with moderate-to-severe plaque psoriasis  In an engaging conversation with…
January 6, 2025

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Prescription Drugs Top 20 2024
TOP 20

Top 20 Prescription Drugs of 2024

Shots: Driven by an endless pursuit of innovation, the biopharma industry is working tirelessly to bring new-age therapies to patients with serious health conditions and lifestyle-influenced diseases In 2023, the global prescription drug market size was valued at $1162.61B and is anticipated to reach $2151.63B by 2032 registering a CAGR of 7.1 %. Keytruda ranks 1st…
October 31, 2024

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Monoclonal Antibodies Top 20 2024
TOP 20

Top 20 Monoclonal Antibodies of 2024

Shots: Transforming care with advanced mechanisms of action, monoclonal antibody therapies hold a strong foothold in the healthcare market In 2021, the monoclonal antibody therapy market size was valued at $178.5B and is envisioned to reach $451.89B by 2028, displaying a CAGR of 14.1%. Keytruda with $25.01B revenue ranks first in our list followed by…
September 12, 2024

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NEWS

Coherus Reports the Divestment of Yusimry (Biosimilar, Humira) to Hong Kong King-Friend Industry

Shots:  Coherus has divested Yusimry under an asset purchase agreement to Hong Kong King-Friend Industry (HKF) granting it global rights & all relevant assets of Yusimry such as its development & regulatory outcomes for $40M upfront  HKF has further granted the US commercial rights of the asset to Meitheal Pharmaceuticals (its subsidiary) under an exclusive…
June 27, 2024

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Teva and Alvotech
NEWS

Teva and Alvotech Launches Simlandi (Biosimilar, Humira) Injection Across US to Treat Multiple Indications 

Shots:  The company has launched Simlandi (citrate-free biosimilar, Humira) injection to treat RA, PsA, AS, UC, Plaque Pso, HS, uveitis, juvenile idiopathic arthritis & CD in the US  The US FDA has approved Simlandi (40mg/0.4mL) injection. Both the low & high concentrations dosing strengths are approved and marketed across the US  The approval was based…
May 20, 2024

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NEWS

Boehringer Ingelheim Partners with Quallent Pharmaceuticals to Expand the Access of Cyltezo (Biosimilar, Humira) 

Shots:  Boehringer Ingelheim has signed an agreement with Quallent Pharmaceuticals to expand the access of citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), across the US  As per the agreement, BI will handle the manufacturing activity of adalimumab-adbm for Quallent and will continue the commercialization of Cyltezo (adalimumab-adbm) injection and Adalimumab-adbm  Quallent will provide high-concentration (40mg/0.4mL)…
May 13, 2024

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Boehringer Ingelheim
NEWS

The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira) 

Shots:  Boehringer Ingelheim has received the US FDA’s approval for the high-concentration (100mg/mL), citrate-free formulation of Cyltezo (biosimilar to Humira) to treat various chronic inflammatory diseases. Its low concentration of 50mg/mL has been available since Jul 2023  The approval was supported partly by the data from P-I (VOLTAIRE-HCLF) evaluating the bioavailability of high-concentration vs low-concentration…
May 1, 2024

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NEWS

Alvotech and Teva’s Simlandi (Biosimilar, Humira) Receives the US FDA’s Approval for the Treatment of Multiple Indications 

Shots:  The US FDA has approved Simlandi injection for treating adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa & uveitis as well as juvenile idiopathic arthritis & Crohn's Disease  The approval was based on a series of studies incl. P-I (AVT02-GL-101) trial comparing the PK, safety & tolerability in…
February 23, 2024

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Insights+ Key Biosimilars Events of October 2023
INSIGHTS+

Insights+ Key Biosimilars Events of October 2023

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 patients  During the month of October, Boehringer launched adalimumab injection (biosimilar, Humira) for multiple…
November 1, 2023

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