STAT

NOVEMBER 1, 2023

The FDA approved Amgen’s biosimilar version of Johnson & Johnson’s blockbuster psoriasis treatment, Stelara, for multiple inflammatory diseases , Reuters says. Stelara, introduced in 2009, has been J&J’s top-selling drug since 2019, with sales reaching $9.7 billion in 2022.

Biosimilars 274

Biosimilars 274

Big Molecule Watch

OCTOBER 11, 2023

FDA grants interchangeable designation to Pfizer’s adaliumumab biosimilar – On October 5, 2023, Pfizer Inc. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). ABRILADA was originally approved by the FDA in November 2019. announced that the U.S.

Biosimilars 64

Biosimilars 64

Pharmaceutical Technology

MAY 19, 2023

Rituxan’s success made it a prime target for biosimilar developers. Globally, the first rituximab biosimilar, Dr Reddy’s Laboratories’ Reditux, was approved in India in 2007. The first approved biosimilar in the US and EU was Celltrion/Teva Pharmaceutical’s Truxima/Blitzima in 2018 and 2017, respectively.

Biosimilars 59

Biosimilars 59

pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. Sales reached a peak in 2019, when Roche booked $1.8 billion, but fell back to $1.4

Biosimilars 72

Biosimilars Labelling Diabetes 72

Pharmaceutical Business Review

MAY 27, 2024

In 2019, it was estimated that 32 million Europeans aged 50 or above had osteoporosis, of which 25.5 In 2022, Henlius and Organon entered into a licensing and supply agreement, granting Organon exclusive rights to commercialise two biosimilar candidates, including HLX14. million were women.

Biosimilars 72

Biosimilars 72

Pharmaceutical Technology

JULY 26, 2022

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of Novartis subsidiary Sandoz for natalizumab, a proposed first-ever multiple sclerosis (MS) biosimilar to reference medicine Tysabri. In 2019, Sandoz and Polpharma Biologics signed an international commercialisation agreement for natalizumab.

Biosimilars 64

Biosimilars Packaging 64

Big Molecule Watch

JULY 25, 2024

Last month, the FDA issued draft guidance, which, if implemented, would remove a requirement for a switching study for demonstrating biosimilar interchangeability.

Biosimilars 49

Biosimilars 49

FDA Law Blog: Biosimilars

APRIL 8, 2025

Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers. Processing voluntary ANDA withdrawals under 21 C.F.R. 314.150(c). Managing the process of issuing Covered Product Authorizations (CPAs) under the CREATES Act.

Documentation 144

Documentation Labelling Drug Development 144

European Pharmaceutical Review

SEPTEMBER 26, 2023

The European Commission (EC) has granted Sandoz the first marketing authorisation of biosimilar Tyruko ®* (natalizumab). Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Sandoz has the rights to commercialise and distribute it in all markets under the deal.

Biosimilars 59

Biosimilars Dosage Packaging 59

Safe Biologics

MAY 21, 2024

Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to ASBM’s Executive Director, Michael Reilly in a r esponse published in GaBI Journal. Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such.

Biosimilars 100

Biosimilars Documentation 100

Big Molecule Watch

MAY 22, 2023

Last week, Amneal announced the launch of FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Amgen’s NEULASTA, in the United States. Amneal developed FYLNETRA in collaboration with Kashiv Biosciences, a biopharmaceutical company located in Chicago, Illinois.

Biosimilars 72

Biosimilars Chemotherapy 72

Express Pharma

AUGUST 8, 2024

The National Health Commission of the People’s Republic of China launched a three-year “Weight Management Year” campaign in June 2024 as part of the broader Healthy China Action (2019-2030) and the Implementation Plan for the Prevention and Control of Obesity in Children and Adolescents.

Biosimilars 102

Biosimilars Diabetes 102

Safe Biologics

JUNE 6, 2024

Executive Director Michael Reilly also attended the conference, where he met with representatives of the cancer community and discussed the IRA’s likely negative impacts on cancer drug research and development, biosimilar competition, and patient access to new innovative therapies. View the resource guide here.

Biosimilars 100

Biosimilars Labelling 100

Safe Biologics

MAY 10, 2023

On May 9th, GaBI Journal published a whitepaper titled “Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars”, based on the recent survey of 41 Canadian ophthalmologists by ASBM and the International Federation on Ageing (IFA). 79% of Canadian, 84% of European, and 67% of U.S.

Biosimilars 100

Biosimilars 100

Safe Biologics

MAY 10, 2023

On May 9th, GaBI Journal published a whitepaper titled “Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars”, based on the recent survey of 41 Canadian ophthalmologists by ASBM and the International Federation on Ageing (IFA). 79% of Canadian, 84% of European, and 67% of U.S.

Biosimilars 100

Biosimilars 100

Big Molecule Watch

DECEMBER 14, 2023

announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. Bio-Thera previously received approval for its TOFIDENCE (tocilizumab-bavi) biosimilar in September 2023. The post Recent Biosimilar Approvals appeared first on Big Molecule Watch.

Biosimilars 45

Biosimilars Diabetes 45

pharmaphorum

SEPTEMBER 20, 2022

Novartis’ soon-to-be-divested Sandoz unit has positive clinical trial data in hand for a biosimilar of Amgen’s blockbuster osteoporosis therapy Prolia (denosumab), clearing the way for regulatory filings. Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and AryoGen Pharmed.

Biosimilars 52

Biosimilars 52

pharmaphorum

JULY 18, 2022

Polpharma has become the first company to file for approval in the EU of a biosimilar version of Biogen’s blockbuster multiple sclerosis therapy Tysabri. It had expected the drug would not face biosimilar competition in Europe until at least 2027.

Biosimilars 52

Biosimilars 52

Express Pharma

MAY 22, 2024

Food and Drug Administration (US FDA) has approved the company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. ” Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics said, “Biosimilars are crucial for making healthcare more affordable and accessible.”

Biosimilars 52

Biosimilars Diabetes Dosage 52

Big Molecule Watch

APRIL 20, 2023

On Monday April 17, 2023, Celltrion announced that it has launched VEGZELMA (bevacizumab-adcd, an AVASTIN biosimilar) in the United States for the treatment of several cancers, including metastatic colorectal cancer and breast cancer. As we previously reported , VEGZELMA was approved by the U.S. pharmaceutical market.

Biosimilars 72

Biosimilars 72

European Pharmaceutical Review

DECEMBER 19, 2022

A biosimilar is a biological medicine ‘similar’ to another biological medicine already approved in the EU (the ‘reference medicine’). 1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product.

Biosimilars 52

Biosimilars 52

Express Pharma

OCTOBER 10, 2023

In May 2023, Alvotech and Advanz Pharma announced an extended strategic partnership with plans to supply and commercialise five proposed biosimilars in Europe, including Simponi. This global study positions AVT05 as the leading contender for Simponi biosimilars in the rheumatoid arthritis (RA) market, says GlobalData.

Biosimilars 52

Biosimilars 52

pharmaphorum

NOVEMBER 17, 2022

The 2019 VPAS , just like its predecessor that was in place from 2014, has at its heart a payback mechanism. That is why companies who are members of the 2019 VPAS have collectively paid back almost £3 billion to the Department of Health and Social Care (DHSC) up to Quarter 2 of 2022. Predictable for government. Variable for companies.

Biosimilars 98

Biosimilars 98

Pharma Pathway

JANUARY 7, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Pass out year: 2019/ 20/ 21/ 22 Passed outs. Experience: Freshers.

Biosimilars 88

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 88

Pharma Pathway

FEBRUARY 26, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world.

Biosimilars 85

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 85

Pharma Pathway

FEBRUARY 14, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world.

Biosimilars 84

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 84

Pharma Pathway

DECEMBER 13, 2022

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Pass out year: 2019/ 2020/2021/ 2022. Dear, Greetings from Hetero…!!

Biosimilars 80

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 80

pharmaphorum

NOVEMBER 16, 2022

Novartis completed the spin-out of Alcon in 2019, separating products like contact lenses and over-the-counter eyedrops from its prescription eye medicines, headed by age-related macular degeneration (AMD) blockbuster Lucentis (ranibizumab), which is partnered with Roche. billion in the first nine months of this year.

Biosimilars 124

Biosimilars Diabetes 124

Pharma Pathway

SEPTEMBER 16, 2022

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Experience: 2019, 2020, 2021, 2022 passed outs only. Designation: Jr.

Biosimilars 79

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 79

Pharma Pathway

SEPTEMBER 13, 2022

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Eligibility: 2019, 2020, 2021, 2022 passed outs Only. Greetings from Hetero…!!

Biosimilars 78

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 78

Pharma Pathway

FEBRUARY 2, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world.

Biosimilars 80

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 80

pharmaphorum

DECEMBER 13, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

Biosimilars 111

Biosimilars 111

Pharma Pathway

FEBRUARY 20, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world.

Biosimilars 78

Biosimilars Pharmaceutical Companies Pharmaceutical Companies 78

pharmaphorum

AUGUST 23, 2021

Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the European Commission approved Samsung Bioepis’ copycat drug Byooviz. Sales reached a peak in 2019, when Roche booked $1.8 billion in sales from the drug while Novartis made $2.1 billion for Roche and $1.9

Biosimilars 40

Biosimilars Diabetes 40

pharmaphorum

FEBRUARY 24, 2021

Higher biosimilar savings. Spain, like many European countries, have seen biosimilars as a route to helping manage pressure on health care spending. Back in 2020 savings from biosimilars were forecasted to really get going in that year and through to 2022. The post 2021 market access prospects for Spain appeared first on.

Biosimilars 100

Biosimilars Immunity Immunization 100

European Pharmaceutical Review

JANUARY 29, 2024

SPC manufacturing waiver Aims and challenges First enacted in 2019, the goal of the SPC manufacturing waiver is to enable the manufacture of medicines, under certain conditions, during the up-to-five-year extension of the market protection of certain patented medicinal products in the EU, Medicines for Europe summarised.

Biosimilars 98

Biosimilars 98

pharmaphorum

DECEMBER 21, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

Biosimilars 126

Biosimilars Chemotherapy Immunity Immunization 126