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GGB Awards Set Stage For Milan In October

The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars

Sandoz Takes Treble Honors At GGB Awards 2023

Sandoz has triumphed at the Global Generics & Biosimilars Awards 2023, taking home three prizes while Samsung Bioepis also walked away with multiple trophies at our prizegiving ceremony in Barcelona.

Generic Drugs Biosimilars Value-Added Medicines
 
Commercial

Samsung Bioepis Achieves Ophthalmology Milestone With Korean Aflibercept Approval

Samsung Bioepis has celebrated becoming the first developer to obtain approvals for both Lucentis and Eylea biosimilars, after its SB15 aflibercept candidate was approved in Korea.

Biosimilars Approvals

Sawai Reports Slight Growth In Japan Amid Challenges

The company’s third quarter results come during its planned withdrawal from the US and the recent implementation of administrative dispositions in Japan on grounds of GMP violations.

Sales & Earnings Manufacturing

Cosette Launches First US Generic To AbbVie’s Rectiv

Approval of Cosette’s first US generic to Rectiv came with a six-month exclusivity as the originator drug had “inadequate generic competition,” but the company has 75 days to enter the market.

Approvals Generic Drugs

GGB Awards Set Stage For Milan In October

The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars
See All
Regulation

French Agency Sets Up New Body To Advise On Biosimilar Substitution

The new committee, which will initially be in place for a year, will advise the French drug regulator when it is preparing its opinions on substitution in specific biosimilar product groups.

Biosimilars France

The Long Read: CEOs Unplug At AAM Conference

The AAM’s annual Access! 2024 conference brought its much-enjoyed CEOs Unplugged panel to Tampa again for another engaging discussion on critical issues, challenges and opportunities for generics and biosimilars in the US.

North America United States

Philippines FDA Slashes Generic Approval Timelines

The Philippines Food and Drug Administration is set to shorten the timeline for generic review and approval from 120 days to just 45 days, as part of efforts to register new generics and bring down prices.

Regulation Policy

Mexico Launches ‘Regulatory Certainty Strategy’ For Biosimilars

Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines.

Mexico Biosimilars
See All
Generic Drugs

Sawai Reports Slight Growth In Japan Amid Challenges

The company’s third quarter results come during its planned withdrawal from the US and the recent implementation of administrative dispositions in Japan on grounds of GMP violations.

Sales & Earnings Manufacturing

Cosette Launches First US Generic To AbbVie’s Rectiv

Approval of Cosette’s first US generic to Rectiv came with a six-month exclusivity as the originator drug had “inadequate generic competition,” but the company has 75 days to enter the market.

Approvals Generic Drugs

GGB Awards Set Stage For Milan In October

The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars

FDA’s New PSG Batch Features GSK’s Inhalers

In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.

United States Guidance Documents
See All
Generic Drugs

Sawai Reports Slight Growth In Japan Amid Challenges

The company’s third quarter results come during its planned withdrawal from the US and the recent implementation of administrative dispositions in Japan on grounds of GMP violations.

Sales & Earnings Manufacturing

Cosette Launches First US Generic To AbbVie’s Rectiv

Approval of Cosette’s first US generic to Rectiv came with a six-month exclusivity as the originator drug had “inadequate generic competition,” but the company has 75 days to enter the market.

Approvals Generic Drugs

GGB Awards Set Stage For Milan In October

The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars

FDA’s New PSG Batch Features GSK’s Inhalers

In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.

United States Guidance Documents

‘Fast Forward Four Or Five Years, We’re Going To Look Very Different’ – Rosemont Chief Eyes ‘Transformative’ International M&A

UK-based liquids specialist Rosemont Pharmaceuticals is on the lookout for M&A opportunities, particularly as it looks to build up its business in the US, chief executive Howard Taylor tells Generics Bulletin in an exclusive interview.

M & A Deals

Samsung Bioepis And Sandoz Get EU Nod For Stelara Rival

Samsung Bioepis has received an EMA nod for its Sandoz-partnered Stelara biosimilar under the name Pyzchiva. Meanwhile, the agency’s CHMP also recommended granting centralized marketing authorizations for two Accord generics.

Biosimilars Generic Drugs

Leaner Kabi Drives Higher Savings Goal For Fresenius, China ‘Soft’ In 2024

Fresenius Kabi insists there is a “business plan behind everything” as it divulged a higher cost savings goal for the end of next year, following a fruitful 2023. But queries over margins led the company to stress that it was combatting a variety of uncertainties, especially in China and for its burgeoning biosimilars unit.

Sales & Earnings Strategy

Generics Are 45% Cheaper In Canada Than In 11 Key Markets

Despite increased pressures from inflation and dependence on international supply chains, the average cost of generics in Canada is 45% lower than in 11 comparator countries, the CGPA reports.

Pricing Debate Generic Drugs

Teva Commits To Dual Branded And Generic Model

Teva’s innovative and generic interests can not only co-exist but are complementary, CEO Richard Francis has set out, in response to questions over whether the Israeli giant would consider splitting its businesses to focus more on branded drugs.

Strategy Generic Drugs

Unipharm Plavix Ruling May Change Game On Recouping Lost Generics Profits In Israel

In a much watched and controversial case that may have significant ramifications on the “chilling effects” of generics manufacturers in Israel being deterred from chasing after approvals in which an originator has deceitfully sought to ‘evergreen’ its branded intellectual property, the Israeli Supreme Court has once again come down on the side of the generics industry.

Legal Issues Intellectual Property

Data Exclusivity Demand In EFTA-India Deal: Access, Licensing, Other Implications

The contentious issue of data exclusivity came to the fore during the European Free Trade Association's negotiations with India for a Free Trade Agreement. What are the arguments in support and against, including impact on compulsory and voluntary licensing?

Intellectual Property Policy

French Proposals On Supply-Chain Security ‘Could Aggravate The Situation’

Proposed French legislation that would address shortages by strengthening obligations to hold security stocks – with the threat of sanctions for suppliers – would be counter-productive, local generics industry association Gemme has warned.

France Legislation
See All
Biosimilars

Samsung Bioepis Achieves Ophthalmology Milestone With Korean Aflibercept Approval

Samsung Bioepis has celebrated becoming the first developer to obtain approvals for both Lucentis and Eylea biosimilars, after its SB15 aflibercept candidate was approved in Korea.

Biosimilars Approvals

GGB Awards Set Stage For Milan In October

The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars

Coherus Delivers First US Rival To Neulasta OnPro, As Biosimilar Interest Peters Out

“Innovating cancer care for patients is a winning strategy,” Coherus said as it delivered on the first US biosimilar version of Amgen’s dominant pegfilgrastim formulation, using an on-body device to deliver the medication, months after a protracted FDA approval.

Biosimilars Value-Added Medicines

Alvotech FDA Approval Clears Path To Challenge Humira

Alvotech and US marketing partner Teva can now launch “imminently” their long-planned rival to Humira, with the firms believing that the Simlandi biosimilar will stand out from the crowd of other adalimumab challengers thanks to a unique combination of product attributes.

Biosimilars Approvals
See All
Value-Added Medicines

GGB Awards Set Stage For Milan In October

The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars

Coherus Delivers First US Rival To Neulasta OnPro, As Biosimilar Interest Peters Out

“Innovating cancer care for patients is a winning strategy,” Coherus said as it delivered on the first US biosimilar version of Amgen’s dominant pegfilgrastim formulation, using an on-body device to deliver the medication, months after a protracted FDA approval.

Biosimilars Value-Added Medicines

‘Fast Forward Four Or Five Years, We’re Going To Look Very Different’ – Rosemont Chief Eyes ‘Transformative’ International M&A

UK-based liquids specialist Rosemont Pharmaceuticals is on the lookout for M&A opportunities, particularly as it looks to build up its business in the US, chief executive Howard Taylor tells Generics Bulletin in an exclusive interview.

M & A Deals

Hikma Launches Combined Pain Relief Drug Combogesic IV In US

Hikma announced the launch of the pain relief solution in the US where it will be sold under the name Combogesic IV as part of a deal with Hyloris Pharmaceuticals.

Launches Value-Added Medicines
See All
Recent Stories

Samsung Bioepis Achieves Ophthalmology Milestone With Korean Aflibercept Approval

Samsung Bioepis has celebrated becoming the first developer to obtain approvals for both Lucentis and Eylea biosimilars, after its SB15 aflibercept candidate was approved in Korea.

Biosimilars Approvals

Sawai Reports Slight Growth In Japan Amid Challenges

The company’s third quarter results come during its planned withdrawal from the US and the recent implementation of administrative dispositions in Japan on grounds of GMP violations.

Sales & Earnings Manufacturing

Cosette Launches First US Generic To AbbVie’s Rectiv

Approval of Cosette’s first US generic to Rectiv came with a six-month exclusivity as the originator drug had “inadequate generic competition,” but the company has 75 days to enter the market.

Approvals Generic Drugs

GGB Awards Set Stage For Milan In October

The Global Generics & Biosimilars Awards returns to Milan this October, recognizing the top achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can also book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars

Coherus Delivers First US Rival To Neulasta OnPro, As Biosimilar Interest Peters Out

“Innovating cancer care for patients is a winning strategy,” Coherus said as it delivered on the first US biosimilar version of Amgen’s dominant pegfilgrastim formulation, using an on-body device to deliver the medication, months after a protracted FDA approval.

Biosimilars Value-Added Medicines

FDA’s New PSG Batch Features GSK’s Inhalers

In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.

United States Guidance Documents

‘Not Just Growth In AG Xyrem’ Hikma Underlines Following Strong 2023

Hikma welcomed a strong and profitable 2023, driven by the nourishing effects of its authorized generic Xyrem product, which will fall back this year as the rate of royalties owed to the brand’s innovator climbs. But the company is optimistic it can continue growth in 2024, including through its $1.2bn Injectables division, which rushed in to fill supply gaps last year.

Sales & Earnings Strategy

‘Fast Forward Four Or Five Years, We’re Going To Look Very Different’ – Rosemont Chief Eyes ‘Transformative’ International M&A

UK-based liquids specialist Rosemont Pharmaceuticals is on the lookout for M&A opportunities, particularly as it looks to build up its business in the US, chief executive Howard Taylor tells Generics Bulletin in an exclusive interview.

M & A Deals

Alvotech FDA Approval Clears Path To Challenge Humira

Alvotech and US marketing partner Teva can now launch “imminently” their long-planned rival to Humira, with the firms believing that the Simlandi biosimilar will stand out from the crowd of other adalimumab challengers thanks to a unique combination of product attributes.

Biosimilars Approvals

Samsung Bioepis And Sandoz Get EU Nod For Stelara Rival

Samsung Bioepis has received an EMA nod for its Sandoz-partnered Stelara biosimilar under the name Pyzchiva. Meanwhile, the agency’s CHMP also recommended granting centralized marketing authorizations for two Accord generics.

Biosimilars Generic Drugs

Sandoz Enters Canada With First Denosumab Biosimilar

Sandoz has truly established its position as the frontrunner in the denosumab race after a Canadian approval, but the path to the US market has been hindered by a lawsuit from the originator Amgen.

Biosimilars Approvals

Leaner Kabi Drives Higher Savings Goal For Fresenius, China ‘Soft’ In 2024

Fresenius Kabi insists there is a “business plan behind everything” as it divulged a higher cost savings goal for the end of next year, following a fruitful 2023. But queries over margins led the company to stress that it was combatting a variety of uncertainties, especially in China and for its burgeoning biosimilars unit.

Sales & Earnings Strategy
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