Complaints from UK originator association the ABPI over rising payments required by the country’s voluntary scheme for branded medicines pricing have been denounced by the BGMA, which says the differentiated scheme is “delivering precisely as it was intended.”

Speaking as Hypera delivered its full year-results, CEO Breno Oliveira has set out plans for the Brazilian firm to launch an Ozempic rival in its domestic market next year. Meanwhile, the company is dealing with increasingly aggressive local generic competition.

Fresenius Kabi is drawing closer to the conclusion of its Vision 2026 strategic roadmap. The company’s CEO, Pierluigi Antonelli, talks to Generics Bulletin about the company’s results so far and how it’s investments in biosimilars, acquisitions and manufacturing is paying off.

The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.

Generics Bulletin reviews global regulatory developments across the globe.

Months on from penning a landmark commercial and manufacturing agreement for GLP-1 assets with Metsera, Amneal says it is happy with how the partnership is shaping up.

Along with financial backing from the Canadian government, a fresh, decade-long partnership with Sandoz Canada will allow Delpharm to carry out modernization plans for its manufacturing facility in Boucherville, securing the local supply chain for sterile injectable medicines.

In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language “the patent” as it applies to patent-term extensions for reissued patents, in the context of Aurobindo’s bid to wipe out a reissued patent shielding Merck & Co’s Bridion (sugammadex) injectable.

Sweden’s Xbrane has struck a deal to transfer its R&D operations in Sweden and its Cimzia (certolizumab pegol) biosimilar candidate to Alvotech, in a transaction worth around $27m. However, Xbrane told Generics Bulletin that it was not getting out of biosimilar development altogether.

Walmart has launched an attack on a host of industry-leading generics firms over historical price-fixing allegations, with the US retail giant seeking treble damages from a Pennsylvania district court.

With Sandoz set to debut US competition to Prolia and Xgeva in a matter of months, other biosimilar sponsors are working hard to ensure launch of Amgen’s blockbuster in a timely manner.

Novartis’ multi-front legal battle against MSN Laboratories over its Entresto blockbuster in the US has taken yet another twist, with a federal district court in New Jersey finding that a preliminary injunction was warranted against MSN’s product on the basis of infringement of Novartis’ trade dress.

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

IGBA secretary general Susana Almeida takes Generics Bulletin through an almost two-decade journey of developing global regulatory convergence and the next goals for the off-patent industry.

Roche is in the crosshairs of the Belgian Competition Authority for delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices”.

Stada has set out annual results that it says demonstrate that the German firm is outperforming the market in all of its business segments, with the company breaking the €4bn sales barrier for the first time. The results come ahead of a long-awaited potential IPO that conflicting rumors suggest could either come very soon indeed, or may be delayed until later this year.

Adalvo and CNX Therapeutics have launched the first extended-release formulation of a pregabalin generic in the UK.

South Africa’s Aspen Pharma has discussed the “significant progress” it believes it has made in GLP-1s, with an eye on rolling-out semaglutide in non-US and non-EU markets beginning as early as 2026.

Amgen’s biosimilar aflibercept formulation is keeping it head and shoulders above other would-be Eylea biosimilar competitors, while continuing to frustrate originator Regeneron’s push to block sales of the product while it battles Amgen over alleged infringement of a key US patent.

Fresenius Kabi has become the latest biosimilar sponsor to settle US litigation with Amgen over its Prolia/Xgeva rivals. The German firm revealed to Generics Bulletin details of launch dates for its denosumab in both the US and Europe.

In a month that saw the average prices of five generic presentations more than double in the UK, WaveData’s figures showed trimethoprim leading the rises with an enormous price increase in February, as several products bounced back from declines in the previous month.

Both vexed by bankruptcies and opioid litigation, Endo and Mallinckrodt will merge in a deal valued at $6.7bn. The new company will spin out its generics and sterile injectable business.

The EU’s Critical Medicines Act is finally here. But did the European Commission’s decision to fast-track the legislation result in it falling short?

Biocon Biologics is partnering with Civica to supply insulin aspart drug substance that will be used for final US manufacturing by Civica at its plant in Petersburg, Virginia.

Delve into the challenges facing the NHS, from rising medicine costs to supply shortages, and how generics and branded generics can provide solutions for a more sustainable healthcare system

Eyeing the lucrative opportunity, three Indian players have launched their generic versions of Boehringer’s anti-diabetes drug Jardiance in their domestic market.

Celltrion has become the latest firm to enter the competitive US market for Stelara biosimilars, revealing details of its Steqeyma launch.

Gedeon Richter enjoyed a solid 2024 as it capitalized on key generic launches and progressed significantly with proposed biosimilars to both Prolia/Xgeva and Actemra/RoActemra. The Hungarian firm also shed light on its strategy over the next decade in a newly-launched ten-year strategic plan.

As Coherus prepares to exit the biosimilars space altogether with the divestment of its Udenyca pegfilgrastim franchise, the firm has set out its annual results for 2024 as well as “organizational streamlining” plans.

Lupin has moved quickly to begin rolling out the first generic version of the blockbuster blood thinner Xarelto in the US, despite continued legal action over a patent expiring in 2039.

Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.

As the US marks 10 years since the first biosimilar approval and launch, AAM Biosimilars Council executive director Craig Burton talks to Generics Bulletin about the lessons learned so far and the path ahead, including how to move on from market models that have proved to be “not appropriate” for biosimilars.

In the wake of multiple ustekinumab biosimilar rivals to Stelara launching in the US at the end of February, Generics Bulletin’s editors discuss the market dynamics and the latest key developments.

Medicines for Europe’s director general described the directive as detrimental to the industry, patients, and the Commission’s ambitions to bolster the supply of critical medicines in the bloc as part of the Critical Medicines Act.

ANI’s generic division and rare disease business have both led to a boost in net revenue for the past quarter and in forecasts for the coming year.

Teva will have to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March, as the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

While Celltrion has scooped approval for the first biosimilar to Genentech/Novartis’ Xolair in the US – where the reference product achieved sales close to $3bn last year – Genentech’s parent Roche has stated consistently that it is not expecting to face biosimilar competition in 2025.

In the wake of Formycon’s recent announcement that US marketing partner Sandoz would be pausing commercialization of the Cimerli rival to Lucentis that it recently took over from Coherus, Sandoz management has offered a few more details on its plans for the ranibizumab biosimilar.

Tariffs, international cooperation, and war: the off-patent industry is not immune to the political issues raging across the globe. Medicines for Europe’s Adrian van den Hoven and Beata Stepniewska spoke with Generics Bulletin about what these developments mean for the sector.

Lupin and Sun Pharma’s Taro, which have just won the first US Food and Drug Administration approvals for generics to J&J/Bayer’s blockbuster Xa inhibitor Xarelto, remain locked in litigation over a patent expiring in 2039.

Marking International Women’s Day, Generics Bulletin speaks to Accord’s UK country manager Clara Carter about her role as chair of the BGMA’s new Women’s Networking Group.

Amneal has spoken excitedly about its Crexont (carbidopa/levodopa) extended-release capsules as the Parkinson’s disease drug passes six months on the market.

Sandoz CEO Richard Saynor has spoken of his frustration at a lawsuit from J&J seeking to prevent the launch of a private-label ustekinumab biosimilar in the US, which he described as “the desperate actions of an originator trying to protect its market.”

Sandoz passed a major milestone in 2024, with the firm’s sales for the first time exceeding $10bn on the back of a significant rise in biosimilars turnover. The company is continuing to push ahead with restructuring initiatives and also addressed the potential threat of US tariffs as management discussed the firm’s annual results.

After receiving an approval for the Neulasta rival in the US in May 2022, Kashiv BioSciences has now added a further North American country with a positive nod from Canada’s health agency.

2025 is likely to be a game-changing year for the pharmaceutical industry. Generics Bulletin sat down with Medicines for Europe’s Adrian van den Hoven and Beata Stepniewska to discuss the opportunities of the Critical Medicines Act and EU pharmaceutical legislation revision.

In a wide-ranging conversation, the AAM’s president and CEO John Murphy talks to Generics Bulletin about how the US industry association is planning to gain traction with the new Trump administration by adopting “a much more aggressive communications approach” on topics including medicines shortages, trade tariffs, PBM reform, the IRA and biosimilar interchangeability.

Amgen has confirmed to Generics Bulletin details of its launch of Bkemv, the first US biosimilar to Soliris.

Ahead of the first biosimilars to denosumab emerging later in the spring, the market is continuing to prove enticing, with Amneal the latest to file for biosimilars to Prolia and Xgeva.

After a successful 2024, Hikma has announced plans to ramp up spending on R&D as part of its ongoing turn towards more complex compounds.

CEO says firm’s “three clear imperatives” to drive cash and “total shareholder return” comprise its “three S” plan. Perrigo’s net sales for the quarter down 1.6% to $1.14bn and for the year down 6.1% to $4.37bn.

Celltrion has become the third firm to win FDA approval for US biosimilar rivals to Prolia and Xgeva. But with multiple denosumab competitors set to launch in just a couple of months, and several more candidates on the way, the market looks likely to be another competitive one for biosimilar sponsors.

Fresenius has become the latest firm to launch a Stelara biosimilar in both the US and Europe, bringing partner Formycon’s Otulfi version to market. But with heavy discounting already seen in the US and multiple competitors already established in the EU, will the firm be able to stand out from the crowd?

Viatris is beginning to deliver on at least one of its complex generic injectables – long-promised by the US company as part of a deep and differentiated pipeline – as it pledged to provide further details at the firm’s upcoming company investor day.

Formycon has celebrated receiving a UK approval for its Ahzantive biosimilar version of Eylea, setting up a launch from partner Teva – which has already seen success in the UK market with the partners’ Lucentis biosimilar, Ongavia.

While there are many unknowns with how incoming Department of Health and Human Services Secretary Robert F. Kennedy Jr. will approach cosmetics regulation, his priorities for drugs and processed foods raises concerns for the cosmetics industry.

Generics Bulletin previews the most noteworthy and anticipated events for March 2025.

Biocon has announced the UK launch of its liraglutide generic rivals to Victoza and Saxenda, hailing a “significant milestone” for the firm’s GLP-1 business, which it expects to be a major growth driver in years to come.

Viatris anticipates that half-a-billion dollars will disappear from its top line in 2025 on the back of the recent import alert for its oral solids facility in Indore, with much of the pain being caused by the firm’s failure to have its generic version of Revlimid exempt from the restrictions.

Following steady updates on its development of a new formulation of valacyclovir, Hyloris revealed the US FDA’s acceptance of its NDA filing while also announcing three new deals this month.

Reporting year-end financials, the Fresenius group spoke at length about its ambition for Fresenius Kabi to reach the billion euro milestone in annual revenues for its prospering Biopharma unit in the coming years, as management also addressed queries about the dynamic pricing environment ahead of the firm’s imminent launch of a biosimilar to Stelara in the US.

South Africa’s Adcock Ingram struck a downbeat tone during its financial first-half results call, as multiple factors conspired to produce a performance “well below expectations.”

Following on a slew of approvals in the past year, Henlius announced the first overseas approval of its Avastin biosimilar in Bolivia where it is partnered with the Brazilian firm Eurofarma.

A new US presidential administration brings both challenges and opportunities for the off-patent industry. Speaking to Generics Bulletin on the sidelines of the AAM’s annual conference earlier this month, the association’s chair and Sandoz North America president Keren Haruvi discusses how the group plans to make its voice heard on key priorities including tariffs, PBM reform, and regulatory streamlining.

Two recent disclosures from Xbrane Biopharma and Formycon demonstrate how the US Food and Drug Administration’s thinking is evolving on the necessity of Phase III trials to support biosimilar filings.

The US Association for Accessible Medicines says it is looking to “protect the public’s interests in ensuring that patents do not let inventors control more than they invented,” as it moved to file in support of MSN Laboratories’ legal tussle with Novartis over a key patent shielding the originator’s $7.8bn Entresto blockbuster.

The same day as Samsung Bioepis and Sandoz launched their partnered Pyzchiva biosimilar rival to Stelara in the US, originator J&J hit the Korean developer with a lawsuit claiming that a private-label commercialization deal with a US pharmacy benefit manager violates the ustekinumab settlement that allowed the firms to launch.

With sales remaining sluggish, on the back of fewer launches, Glenmark’s management nevertheless struck an upbeat tone when discussing the firm’s prospects in the US moving into the company’s 2026 financial year.

The UK’s NHS and Sandoz have both told Generics Bulletin that they are looking into reports from a single UK hospital of adverse reactions linked to patients that have switched from Tysabri to Sandoz’s Tyruko biosimilar.

As more Stelara biosimilars pile into the US market – including launches from Alvotech/Teva, Samsung Bioepis/Sandoz and Biocon – the latest reports suggest that price competition for ustekinumab rivals could be fierce.

The Global Generics & Biosimilars Awards is taking place in Frankfurt this October, with the event returning to Germany in its twelfth year for an even bigger and better awards ceremony that will recognize the most outstanding 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.

The IGBA has introduced its first global intellectual property and competition report, addressing the urgent need to reform current regulations. But, in a bid to increase access to medicines across the world, did it stop short at just IP and patents?

Reformulation specialist Lipella has an eye on numerous milestones for its proposed oral rinse liposomal formulation of tacrolimus, including the submission of a Phase IIb clinical trial investigational new drug application.

Generics Bulletin reviews the latest regulatory developments across the world.

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

In an update to its strategy for dealing with US tariffs, Korea’s Celltrion has revealed actions taken so far, as well as outlining plans to consider moving “swiftly” to secure US manufacturing for APIs if circumstances demand.

While quarterly revenues show ups and downs in each region, Lupin is set on continued growth, with a touch of complexity and innovation – including shifting its thinking on the attractiveness of biosimilars.

A journey began eight years ago continues for Doc Generici – now rebranded as DOC Pharma – as it continues to diversify its offerings beyond conventional generic prescription pharmaceuticals.

Cosette Pharmaceuticals has made two key executive appointments as it looks to build up its business. Meanwhile, Canada’s CGPA has named a chair and vice-chair, and Chanelle and Neuraxpharm have announced their own executive changes.

The Polish player has won two grants sourced from the government’s National Recovery and Resilience Plan, which has given out $28.1m in funding in the latest round.

Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.

A month after Vanda failed to win a trade secrets case against the US FDA corresponding to generic approvals for its brands Hetlioz and Fanapt, the originator has again fallen, this time to the agency and Teva in the alleged unlawful approval of the Israeli firm’s generic Hetlioz product.

In its latest draft standard contract for 2025/26, the National Health Service in England has proposed enhanced prescribing requirements “in recognition of the increasing importance of biosimilars in the provision of biological medicines.”

Samsung Bioepis is only the second firm to receive a US FDA endorsement for its denosumab biosimilars, with the nod coming at the same time as formal European Commission approval. But plenty more firms are waiting in line with their own rivals to Prolia and Xgeva.

Sanofi has bolstered its insulin offerings by bagging the first US FDA approval for a rapid-acting insulin aspart biosimilar, leaving several would-be sponsors in its wake.

In an exclusive interview with Generics Bulletin, Aspargo Labs CEO Michael Demurjian discusses the importance of reformulated liquid oral suspension drugs, while outlining plans to launch a smart device that connects patients and doctors.

Zydus’ latest results faced scrutiny from industry analysts due to a mixed performance where weaker revenue in the Indian company’s domestic market was offset by growth in the US. Meanwhile, the firm has just agreed a deal with Synthon for a 505(b)(2) hybrid product in the US.

Adial Pharmaceuticals’ CEO Cary Claiborne discussed with Generics Bulletin how repurposing antinausea drug ondansetron and genetically targeting patients with specific biomarkers can address the unmet need in the current treatment of addiction.

Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.

Canada’s largest generics manufacturer Apotex will look to expand its channels to include health food stores, new professional channels including naturopathic doctors, and grocery retail channels, after acquiring Ontario-based natural health firm CanPrev for an undisclosed sum.

Discussing a new report highlighting the lack of US biosimilar competition on the cards for the majority of biologics losing exclusivity in the next ten years, the AAM’s Access! 2025 conference heard that the “sobering” findings should act as a “wake-up call for stakeholders.”

Teva will have to wait until the end of the next decade to launch its proposed generic version of Axsome Therapeutics’ Auvelity treatment for MDD.

Biocon Biologics’ management shared updates regarding their facilities, expansion, and fast upcoming ustekinumab biosimilar launch in the US. Also, Biocon made a final acquisition payment to Viatris, while increasing its stake in the biosimilars business.

Having recently acquired Coherus’ biosimilar pegfilgrastim franchise in the US and welcomed FDA approval for its partnered ustekinumab biosimilar, Accord Biopharma is again spending big to flesh out its US biosimilar pipeline.

Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’

India’s Gland Pharma had much to discuss during its financial third-quarter earnings call, including a recent CDMO partnership with China’s Shanghai Henlius Biotech that could lead to the establishment of further manufacturing space to meet demand.

Bio-Thera Solutions has taken the next step towards launching competition to Johnson & Johnon’s Simponi blockbuster, filing its Stada-partnered BAT2506 golimumab candidate with Europe’s regulatory body following successful Phase III comparison data.

While the UK Court of Appeal’s decision in Merck Serono v Comptroller-General will be unwelcome by innovators, it provides much-needed certainty for companies seeking – or seeking to invalidate – supplementary protection certificates based on marketing authorizations for new uses of known active ingredients.