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Shortlist Revealed Ahead Of October Awards
Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.
Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity
Amneal Outlines Ambitions To Become Leading Affordable Medicines Supplier In US
Rani Takes Next Step As Oral Ustekinumab Biosimilar Enters The Clinic
Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim
Interviews
‘There Is Always Room For Improvement’: Celltrion Reflects On A Decade Of European Biosimilars
Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.
Latest Articles

Judges Weigh Record Entries Ahead Of October’s GGB Awards
Now in its tenth year, the Global Generics & Biosimilars Awards has received a record-breaking number of entries in 2023. Judges are now evaluating the nominees ahead of our awards ceremony on Wednesday 25 October at the Hotel Porta Fira in Barcelona.
Commercial

Shortlist Revealed Ahead Of October Awards
Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.

Rani Takes Next Step As Oral Ustekinumab Biosimilar Enters The Clinic
As biosimilars to Stelara (ustekinumab) continue to advance in global markets, Rani Therapeutics has made progress for its proposed RT-111 orally administered ustekinumab biosimilar.

Amneal Outlines Ambitions To Become Leading Affordable Medicines Supplier In US
While it currently sits in fourth place, Amneal’s co-CEO Chirag Patel has laid out ambitions for the firm to become the number one supplier of affordable medicines in the US.

Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity
As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.
Regulation

Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity
As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.

Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim
Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

‘There Is Always Room For Improvement’: Celltrion Reflects On A Decade Of European Biosimilars
Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.

Amgen’s $27.8bn Horizon Takeover Stipulates Biosimilar Restrictions
The FTC’s proposed consent order allowing Amgen to move ahead with its mammoth takeover of Horizon includes an interesting stipulation for industry – one involving biosimilars.
Generic Drugs

Shortlist Revealed Ahead Of October Awards
Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.

Amneal Outlines Ambitions To Become Leading Affordable Medicines Supplier In US
While it currently sits in fourth place, Amneal’s co-CEO Chirag Patel has laid out ambitions for the firm to become the number one supplier of affordable medicines in the US.

US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

Takeda Pens Mid-Trial Settlement To Dismiss US Colcrys Antitrust Suit
Japanese originator Takeda has agreed to settle two-year-old anticompetitive claims lodged by wholesalers in the US that it conspired with several generics manufacturers to maintain supracompetitive pricing for its Colcrys branded treatment for gout.
Biosimilars

Shortlist Revealed Ahead Of October Awards
Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.

Rani Takes Next Step As Oral Ustekinumab Biosimilar Enters The Clinic
As biosimilars to Stelara (ustekinumab) continue to advance in global markets, Rani Therapeutics has made progress for its proposed RT-111 orally administered ustekinumab biosimilar.

Amneal Outlines Ambitions To Become Leading Affordable Medicines Supplier In US
While it currently sits in fourth place, Amneal’s co-CEO Chirag Patel has laid out ambitions for the firm to become the number one supplier of affordable medicines in the US.

Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity
As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.
Value-Added Medicines

Shortlist Revealed Ahead Of October Awards
Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.

Rani Takes Next Step As Oral Ustekinumab Biosimilar Enters The Clinic
As biosimilars to Stelara (ustekinumab) continue to advance in global markets, Rani Therapeutics has made progress for its proposed RT-111 orally administered ustekinumab biosimilar.

Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim
Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

Teva’s Francis: I Looked At All The Sexy Stuff And Overlooked Olanzapine
After launching the Uzedy long-acting formulation of risperidone in partnership with MedinCell earlier this year, Teva has stressed the “really exciting” product profile of another long-acting antipsychotic from the partnership, olanzapine, while discussing how it will avoid the safety pitfalls of legacy products in the space.
Recent Stories
Shortlist Revealed Ahead Of October Awards
Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.
Rani Takes Next Step As Oral Ustekinumab Biosimilar Enters The Clinic
As biosimilars to Stelara (ustekinumab) continue to advance in global markets, Rani Therapeutics has made progress for its proposed RT-111 orally administered ustekinumab biosimilar.
Amneal Outlines Ambitions To Become Leading Affordable Medicines Supplier In US
While it currently sits in fourth place, Amneal’s co-CEO Chirag Patel has laid out ambitions for the firm to become the number one supplier of affordable medicines in the US.
Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity
As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.
Alvotech’s Japanese Ustekinumab Nod Is ‘First For Global Markets’
Following the formation of their partnership nearly five years ago, Alvotech and Fuji have together welcomed approval in Japan for Alvotech’s biosimilar to Stelara (ustekinumab).
Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim
Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”
Sandoz Prepares For European Natalizumab Launch As Approval Arrives
As it announced the formal European Commission approval of its partnered Polpharma Biologics-developed Tyruko natalizumab biosimilar to Tysabri, Sandoz offered Generics Bulletin a timeframe for its expected launch in Europe.
US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage
Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.
‘There Is Always Room For Improvement’: Celltrion Reflects On A Decade Of European Biosimilars
Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.
Fresenius Kabi Gets Ready To Launch Europe’s First Tocilizumab Rival
Fresenius Kabi has celebrated the approval of Europe’s first tocilizumab biosimilar. The rival to RoActemra is expected to be launched later this year under a settlement agreement with originator Genentech.
BioFactura Completes Phase I For Late-To-Market Stelara Biosimilar
BioFactura has completed a successful Phase I trial of its Stelara (ustekinumab) biosimilar BFI-751, which is expected to file in developed markets in 2026.
Glenmark Divests API Company, Setting Out On Distinct Journeys
Glenmark Pharmaceuticals has divested its API arm to the Nirma group for over $681m, a move that will deleverage the drug maker’s balance sheet as it seeks to evolve into an “innovative/brand led organization.”
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