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Interviews

Interviews

European Solutions To European Problems – Securing The Supply Of Critical Medicines

European solidarity and dialogue will be key as the region seeks to secure its supply of critical medicines, says Victor Mendonça, board member of Medicines for Europe. In an exclusive interview, he speaks to Generics Bulletin about what can be done to strengthen Europe’s supply chain without “one country’s solution being another country’s problem.”

Supply Chain Generic Drugs

Podcast: The Global Generics & Biosimilars Awards 2024

In a podcast discussion, Generics Bulletin’s editors talk about how you can enter and attend the Global Generics & Biosimilars Awards, what makes for a good entry, and why companies and individuals will want to get involved in the event.

Generic Drugs Biosimilars Value-Added Medicines
 
Commercial

Gedeon Richter Is Latest To File European Denosumab

Gedeon Richter has revealed that its European filing for a denosumab biosimilar rival to Prolia/Xgeva has been accepted for review by the EMA.

Biosimilars Europe

And They’re Off! First Stelara Biosimilar Enters European Markets

Stada and Alvotech have heralded the start of biosimilar competition to Stelara in Europe with the launch of their partnered Uzpruvo version.

Biosimilars Launches

Krka Enjoys 9% Pharma Sales Growth At The Half-Way Stage

Krka insisted that its margins were “stable and high,” as the Slovenian firm reported another solid quarter.

Sales & Earnings Strategy

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Policy Regulation
See All
Regulation

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Policy Regulation

Regulatory Recap: US Senate Passes Anti-Patent Thicket Bill, EU Council Debates Pharma Package

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

Regulation Generic Drugs

Biosimilars Report Bolsters IGBA’s Calls To Streamline Development Process

The IGBA has renewed calls to streamline biosimilar development by reducing comparative clinical studies and using the same comparator product across international jurisdictions, citing the findings of a recent publication by the International Pharmaceutical Regulators Programme’s Biosimilars Working Group.

Biosimilars Clinical Trials

South Africa Drops J&J Bedaquiline Scrutiny After Generic Market Opens Up

Johnson & Johnson’s actions to promote generic competition and lower the price for its crucial tuberculosis treatment, Sirturo (bedaquiline), have satisfied an investigation launched by South Africa’s Competition Commission.

Regulation Policy
See All
Generic Drugs

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Policy Regulation

Regulatory Recap: US Senate Passes Anti-Patent Thicket Bill, EU Council Debates Pharma Package

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

Regulation Generic Drugs

Entering The GGB Awards: One Week To Go!

An additional week has been added to the deadline for companies to submit their entries for the Global Generics & Biosimilars Awards 2024, ahead of our ceremony in Milan on 9 October.

Generic Drugs Biosimilars

Re-Elected Von Der Leyen Sets Out EU Commission Plans For Critical Medicines Act

As she was re-elected as president of the European Commission, Ursula von der Leyen set out plans for the next European Commission that include a Critical Medicines Act to secure the supply chain.

Europe Supply Chain
See All
Generic Drugs

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Policy Regulation

Regulatory Recap: US Senate Passes Anti-Patent Thicket Bill, EU Council Debates Pharma Package

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

Regulation Generic Drugs

Entering The GGB Awards: One Week To Go!

An additional week has been added to the deadline for companies to submit their entries for the Global Generics & Biosimilars Awards 2024, ahead of our ceremony in Milan on 9 October.

Generic Drugs Biosimilars

Re-Elected Von Der Leyen Sets Out EU Commission Plans For Critical Medicines Act

As she was re-elected as president of the European Commission, Ursula von der Leyen set out plans for the next European Commission that include a Critical Medicines Act to secure the supply chain.

Europe Supply Chain

Hikma Launches First US Sodium Acetate With CGT Exclusivity

Following on from a flurry of deal and launches, Hikma has released another product onto the US market with the first of its sodium acetate injections, bolstered by 180 days of Competitive Generic Therapy exclusivity. 

BioPharmaceutical United States

UK Prices Continue To Shoot Up In June

The latest UK generic pricing information from WaveData shows multiple products doubling or even trebling their average prices in June.

Market Intelligence Pricing Strategies

PBMs Hinder Access To Generics And Biosimilars, Finds FTC’s Investigation

An FTC report has shown evidence of “troubling rebating practices” between pharma companies and PBMs, lowering access to generics and biosimilars. While off-patent groups commended the agency, the PBM association said the report falls short of being definitive or fact-based.

Legislation Market Access

US FDA’s Cavazzoni To Manufacturers: Pay Attention To Data Received From CROs

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

Compliance Quality

Olainfarm Becomes Olpha And Sets Out European Strategy

Latvia’s Olainfarm has rebranded itself as Olpha, setting out its ambitions to become a top 10 pharmaceutical company in Europe and achieve turnover of “at least €1bn over the next ten years”.

Strategy Europe

Viatris’ Mylan and Former President Malik Released From DoJ Scrutiny

Viatris will be able to walk away from years-old US Department of Justice investigations into alleged price fixing, including against its former president Rajiv Malik.

Legal Issues Pricing Debate

What Does Labour’s UK Election Win Mean For Generics And Biosimilars?

With the UK’s Labour party securing a substantial majority in the country’s general election, the BGMA has spoken to Generics Bulletin about the benefits that it hopes to see from a change in government.

Politics Policy

FDA Approves First Generic Exparel – But What Will The Courts Say?

Despite the first and only US FDA approval, Jiangsu Hengrui’s US eVenus has been tipped to stay out of the generic Exparel market until at least the end of the 2030s. Generics Bulletin investigates.

Generic Drugs Approvals
See All
Biosimilars

Gedeon Richter Is Latest To File European Denosumab

Gedeon Richter has revealed that its European filing for a denosumab biosimilar rival to Prolia/Xgeva has been accepted for review by the EMA.

Biosimilars Europe

And They’re Off! First Stelara Biosimilar Enters European Markets

Stada and Alvotech have heralded the start of biosimilar competition to Stelara in Europe with the launch of their partnered Uzpruvo version.

Biosimilars Launches

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Policy Regulation

Regulatory Recap: US Senate Passes Anti-Patent Thicket Bill, EU Council Debates Pharma Package

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

Regulation Generic Drugs
See All
Value-Added Medicines

Amneal Launches Polysorbate-Free Fosaprepitant In The US

Marking the firm’s second launch of a 505(b)(2) injectable this year, Amneal has released Focinvez in the US as an antiemetic agent used in chemotherapy regimens.

United States BioPharmaceutical

Entering The GGB Awards: One Week To Go!

An additional week has been added to the deadline for companies to submit their entries for the Global Generics & Biosimilars Awards 2024, ahead of our ceremony in Milan on 9 October.

Generic Drugs Biosimilars

Hyloris Replaces Leadership After Continued Transaction Woes

Marking a further development in the story of Hyloris’ in-licensing deal with QliniQ, the company’s board has announced significant leadership and organizational changes to address potential concerns.

BioPharmaceutical Belgium

Rosemont Delivers On US Expansion Plans By Snapping Up Sabal

UK liquids specialist Rosemont Pharmaceuticals has delivered on promises to expand into the US market by striking a deal to acquire Georgia-based distributor Sabal Therapeutics.

Deals M & A
See All
Recent Stories

Gedeon Richter Is Latest To File European Denosumab

Gedeon Richter has revealed that its European filing for a denosumab biosimilar rival to Prolia/Xgeva has been accepted for review by the EMA.

Biosimilars Europe

And They’re Off! First Stelara Biosimilar Enters European Markets

Stada and Alvotech have heralded the start of biosimilar competition to Stelara in Europe with the launch of their partnered Uzpruvo version.

Biosimilars Launches

Krka Enjoys 9% Pharma Sales Growth At The Half-Way Stage

Krka insisted that its margins were “stable and high,” as the Slovenian firm reported another solid quarter.

Sales & Earnings Strategy

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Policy Regulation

Amneal Launches Polysorbate-Free Fosaprepitant In The US

Marking the firm’s second launch of a 505(b)(2) injectable this year, Amneal has released Focinvez in the US as an antiemetic agent used in chemotherapy regimens.

United States BioPharmaceutical

Regulatory Recap: US Senate Passes Anti-Patent Thicket Bill, EU Council Debates Pharma Package

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

Regulation Generic Drugs

Entering The GGB Awards: One Week To Go!

An additional week has been added to the deadline for companies to submit their entries for the Global Generics & Biosimilars Awards 2024, ahead of our ceremony in Milan on 9 October.

Generic Drugs Biosimilars

J&J Confirms EU Stelara Biosimilars Are Imminent

One of the largest biologic opportunities for inflammatory bowel disorders, Johnson & Johnson’s Stelara, will open up to biosimilar competition in a matter of days, the originator has confirmed.

Biosimilars Commercial

Re-Elected Von Der Leyen Sets Out EU Commission Plans For Critical Medicines Act

As she was re-elected as president of the European Commission, Ursula von der Leyen set out plans for the next European Commission that include a Critical Medicines Act to secure the supply chain.

Europe Supply Chain

Xbrane Inching Closer To Cimzia Biosimilar Trials With Batch Production

Sweden’s Xbrane Biopharma has delivered updates for two of its more long-term projects, including a proposed biosimilar to Bristol Myers Squibb’s Opdivo for which it is actively seeking a partner.

Biosimilars Manufacturing

Hikma Launches First US Sodium Acetate With CGT Exclusivity

Following on from a flurry of deal and launches, Hikma has released another product onto the US market with the first of its sodium acetate injections, bolstered by 180 days of Competitive Generic Therapy exclusivity. 

BioPharmaceutical United States

Zydus’s ‘Transparency Failure’ Leads To Block On Indian Perjeta Biosimilar

The principles of fairness in procedural conduct, especially in commercial disputes, is crucial,” Delhi’s High Court told Zydus Lifesciences as it agreed to temporarily block the sale of the firm’s recently launched biosimilar to Roche’s Perjeta.

Legal Issues Biosimilars
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