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…

ByDipanshu DixitFebruary 23, 2024

INSIGHTS+

Insights+ Key Biosimilars Events of June 2023

Shots: 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 June, Samsung Bioepis presented results of SB12…

BySenior EditorJuly 5, 2023

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Insights+: The US FDA New Drug Approvals in May 2023

Shots: The US FDA approved 15 NDAs and 3 BLA in May 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 54 novel products in 2023 In May 2023, the major highlights drugs were, Ayvakit approval for Indolent Systemic Mastocytosis, Rinvoq for Active Crohn's Disease PharmaShots has…

BySenior EditorJune 21, 2023

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Insights+: The US FDA New Drug Approvals in April 2023

Shots: The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023 In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

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Insights+ Key Biosimilars Events of April 2023

Shots: 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 April, Sandoz’s Hyrimoz (biosimilar, adalimumab) received EC’s…

BySenior EditorMay 3, 2023

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Insights+ Key Biosimilars Events of January 2023

Shots: 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 January, Celltrion reported P-III trial results of…

BySenior EditorFebruary 1, 2023

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Insights+: EMA Marketing Authorization of New Drugs in August 2022

The EMA approved 5 New Chemical Entity (NCE) and 4 Biologic Drugs in August 2022, leading to treatments for patients and advances in the healthcare industry In August 2022, the major highlights drugs were Lynparza’s approval for breast cancer, Imbruvica (ibrutinib) for chronic lymphocytic leukaemia, Sunlenca (lenacapavir) for HIV Infection PharmaShots has compiled a list…

BySenior EditorSeptember 28, 2022

INSIGHTS+

Insights+ Key Biosimilars Events of August 2022

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 August, Formycon reported P-III (VESPUCCI) trial results of…

BySenior EditorSeptember 1, 2022

INSIGHTS+

Insights+ Key Biosimilars Events of May 2022

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 May, JSR Life Sciences launches Similis Bio business…

BySenior EditorJune 2, 2022

TOP 20

Top 20 Generics Pharma Companies Based On 2020 Revenue

Shots: Generic medicines are the backbone of the healthcare system and are identical to the innovator medicine in strength- effect- dosage form- and route of administration. These are allowed for sale after the patent expiry of the original drugs Our team at PharmaShots has compiled a list of the top 20 generic companies based on…

ByPrince GiriOctober 28, 2021

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

Insights+ Key Biosimilars Events of June 2023

Insights+: The US FDA New Drug Approvals in May 2023

Insights+: The US FDA New Drug Approvals in April 2023

Insights+ Key Biosimilars Events of April 2023

Insights+ Key Biosimilars Events of January 2023

Insights+: EMA Marketing Authorization of New Drugs in August 2022

Insights+ Key Biosimilars Events of August 2022

Insights+ Key Biosimilars Events of May 2022

Top 20 Generics Pharma Companies Based On 2020 Revenue

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