Thursday, March 13, 2025

Lupin Risks First US Xarelto Generic Launch After PTAB Knocked Out Key Patent

(3/12, Dean Rudge, Generics Bulletin) ...Lupin has pressed on ‘at-risk' with the launch of the first generic version of Johnson & Johnson/Bayer's blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets, with litigation ongoing over a key patent expiring in 2039...The FDA is yet to publish the ANDA approval letter for Lupin's product which would help shed more light on the current status of patent-infringement litigation proceedings...Boosting prospects for ANDA sponsors, claims of the ‘310 patent were declared invalid by the US Patent and Trademark Office's Patent Trial and Appeal Board in inter partes review proceedings initiated by Viatris, with Teva and Invagen joining... Global Sub. Full

Celltrion Launches Stelara Biosimilar in US

(3/13, Park Soo-bin, The Korea Herald) ...Celltrion is launching Steqeyma at an 85 percent lower wholesale acquisition cost, or WAC, than Stelara. The company said this pricing strategy is expected to enhance profitability in the US insurance market, where high rebate rates are common. The company also aims to attract major pharmacy benefit managers and uninsured patients under the lower WAC version with reduced rebates. Celltrion is currently under negotiation with leading PBMs, including the three largest in the US, with some contracts nearing completion... Full

The Generics Bulletin Podcast: Stelara Biosimilar Launches In The US

(3/12, Dave Wallace, Generics Bulletin) ...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... Global Sub. Full

Axsome Drops Generics Maker Hikma From Sunosi Drug Patent Case

(3/12, Christopher Yasiejko, Bloomberg Law) ...A federal judge granted a joint request to drop Axsome Therapeutics Inc.'s patent claims against Hikma Pharmaceuticals Plc over proposed copies of Sunosi, leaving three generic-drug makers in the consolidated lawsuit...The consolidated case also involves generic-drug makers Alkem Laboratories Ltd., Aurobindo Pharma Ltd., and Hetero Labs Ltd. Axsome alleges their applications for US Food and Drug Administration approval of generic solriamfetol oral tablets infringe its Sunosi-related patents... Sub. Req’d

Drugmakers Mallinckrodt and Endo to Merge in Nearly $7 Billion Deal

(3/13, Sneha S K and Sriparna Roy, Reuters) ...Mallinckrodt and Endo, drugmakers with a shared history of facing U.S. opioid litigation, have agreed to merge in a deal valued at nearly $7 billion...Mallinckrodt and Endo plan to combine their generic pharmaceuticals businesses and Endo's sterile injectables business after the close of the deal and intend to separate that business from the combined company at a later date... Full

'Aurobindo Pharma Isn't Just Chasing Growth...' - Diversification and Expansion Set Stage for Next Phase of Growth - What CFO REVEALED | ET NOW On The Go Hyderabad Edition

(3/13, Anjali Palod, ET NOW) ... Aurobindo Pharma isn't just chasing growth—it's making sure it lasts. The leading drugmaker is focused on sustaining profitability and turnover, according to Chief Financial Officer Santhanam Subramanian. Amid rising global uncertainties, the company plans to achieve this with a clear vision centered on scale and diversity, he told ET Now in an exclusive interview. The company isn't content with just one area of focus; it's actively expanding into new verticals like injectables, peptides, and biosimilars, while simultaneously broadening its geographical footprint beyond India... Full

Boehringer Ingelheim Teams with Veeva to Launch New R&D Platform One Medicine

(3/12, Darren Incorvaia, Fierce Biotech) ...Two years after first announcing a partnership, Boehringer Ingelheim and software firm Veeva Systems have launched Boehringer's One Medicine platform to help the German pharma streamline its product development by bringing together clinical, regulatory and quality data processes. Boehringer plans to use One Medicine to boost its development of new medicines, the company said in a March 11 release, by linking data across functions and improving trial efficiency and collaboration with research sites... Full

CMS Cancels Two Biden-Era Drug Cost-Cutting CMMI Demos

(3/12, Gabrielle Wanneh, Inside Health Policy) ...The Trump administration will not move forward with two prescription drug payment demonstrations announced by the CMS Innovation Center in 2023 that would have set $2 copays for select generic drugs covered by Medicare and incentivized drug makers to complete the confirmatory trials for treatments granted accelerated approval by FDA... Sub. Req’d

Medicare Agency to End Some Demonstration Projects, Cancel $2 Generic Drug Initiative

(3/12, Anna Wilde Mathews, The Wall Street Journal) ...CMS said it was ending the projects after a "comprehensive and data-driven review of our model portfolio based on the clear statutory mandate given to the Center by Congress." A CMS official said the terminated projects were deemed unlikely to meet mandated targets of improvements in care quality and/or cost savings... Sub. Req’d

Trump Accuses Ireland of Stealing US Companies in Meeting with Taoiseach

(3/12, Lisa O'Carroll, The Guardian) ...Donald Trump has accused Ireland of stealing the US pharmaceutical industry and the tax revenue that should have been paid to the US treasury, in a blow to the Irish premier, Micheál Martin, who had hoped to emerge unscathed from a visit to the White House marking St Patrick's Day...He repeatedly took aim at Ireland's historical low-tax policies, which helped lure US multinationals including Pfizer, Boston Scientific and Eli Lilly to its shores. Big pharma now drives Ireland's €72bn (£60bn) worth of annual exports to the US, with taxes paid in Ireland on drugs consumed in the US... Full

‘Ireland Has Our Pharma Companies,' Says Trump. But What Will He Do About It?

(3/12, Cliff Taylor, The Irish Times) ...Tariffs remain his weapon of choice, to try to achieve this. Imposing them on imports of pharma into the US would upset the business models of the big companies. His rhetoric is already having an impact, with some big firms with operations here – such as Eli Lilly – promising to invest more in the US. Whether this is at the expense of investment here is not entirely clear, though if tariffs are introduced pharma companies are likely to use any spare capacity in the US in the short term and cut production in overseas locations like Ireland. Pfizer, another big investor here, has already indicated it may use this approach... Full

Trump's $1.4 Trillion Tariff Threat Spurs Firms to Seek Cover

(3/12, Albertina Torsoli, Bloomberg Law) ...Ozempic-maker Novo Nordisk A/S is planning to make more of its medicines for the US market locally; Boeing Co. risks a gummed up supply chain and higher aircraft costs it may not be able to pass on; Chinese online retailer Shein Group Ltd. is offering incentives to its top apparel providers to set up new production capacity in Vietnam. Companies across the world are looking for cover from President Donald Trump's frenzied tariff barrage, planning for the worst even as reversals and exemptions leave them desperately seeking clarity...

After A Decade Of US Biosimilars, ‘The Challenges Are Becoming More Clear'

(3/12, Dave Wallace, Generics Bulletin) ...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... Global Sub. Full

CMS Extends Registration For Roundtables On IRA Drug Negotiations

(3/12, Sigi Ris, Inside Health Policy) ...CMS is giving patients, caregivers, researchers, advocacy organizations and other health care stakeholders extra time to register for Medicare drug price negotiation public engagement events, extending the deadline through March 19, the agency announced Wednesday (March 12)... Sub. Req’d

Tillis, Colleagues Introduce Bipartisan Bill to Strengthen Medical Supply Chains

(3/12, U.S. Senator for North Carolina Thom Tillis) ...Today, Senators Thom Tillis (R-NC), Chris Coons (D-DE), John Cornyn (R-TX), and Michael Bennet (D-CO) introduced the Medical Supply Chain Resiliency Act, bipartisan legislation that would provide the United States with greater ability to engage in trade negotiations in order to ensure that critical medical goods and services are delivered safely, swiftly, and efficiently to patients in the United States and around the world... Full

Strong Trade Policies Protect American Workers and Biopharmaceutical Innovation

(3/12, Douglas Petersen, PhRMA) ...President Trump has made it clear that his administration is focused on supporting American workers and manufacturers, while tackling unfair and non-reciprocal trade practices by foreign governments. PhRMA and its members share these goals. To help inform the administration's America First Trade Policy, PhRMA submitted comments to the U.S. Trade Representative (USTR) highlighting policies abroad that harm American biopharmaceutical innovation and leadership... Full

Telehealth Platforms in Senators' Crosshairs Over Relationship with Eli Lilly, Pfizer

(3/12, Katie Palmer, STAT+) ...On Tuesday, a group of senators sent letters to five telehealth companies that offer care through direct-to-consumer portals from pharmaceutical manufacturers Pfizer and Eli Lilly, interrogating their financial relationships. The questions seek to determine whether contracts between pharma and telehealth companies could violate the federal anti-kickback statute... Sub. Req’d

They Said It!: Lawmakers And FDA Nominee Highlight Greater Competition As Critical To Lowering Prescription Drug Prices

(3/12, The Campaign for Sustainable Rx Pricing) ...On Thursday, the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) held a confirmation hearing for Dr. Martin Makary's nomination to serve as Commissioner of the U.S. Food and Drug Administration (FDA). During the hearing, Dr. Makary and lawmakers from both parties discussed the importance of supporting greater biosimilar and generic competition to help lower prescription drug prices, including by addressing Big Pharma's abuse of the patent system. In response to a question from U.S. Senator Maggie Hassan (D-NH), where she noted Big Pharma has already hiked prices on more than 500 prescription drugs so far this year, Dr. Makary pointed to cracking down on patent abuse as critical for fostering more competition in the market... Full

Don't Ask, Don't Tell: Senate Democrats Ready To Embrace Makary Heading US FDA

(3/12, Michael McCaughan, Pink Sheet) ...Senators avoided many tough questions during the confirmation hearing for FDA Commissioner nominee Martin Makary. Many Senate HELP Committee members seemed to accept Makary's answer to questions about the recent layoffs at the FDA, but wanted more information on who would make hiring decisions. Makary only committed to assessing the FDA workforce... Global Sub. Full

CT Legislators Take Aim at High Cost of Prescription Drugs

(3/12, Katy Golvala, CT Mirror) ...State lawmakers presented legislation this week aimed at tackling the rising cost of prescription drugs, which they say is a major driver in the cost of health care — leaving Connecticut families struggling and leading to cost overruns in the state budget...The group's conclusions, outlined in a final report and encompassed in House Bill 7192, call for regulating pharmacy benefit managers, increasing price transparency, and studying Canadian drug imports and drug shortage mitigation strategies... Full

EU's Critical Medicines Act: A Major Milestone Or Too Weak?

(3/12, Neena Brizmohun, Pink Sheet) ...Its publication was said to be "a major milestone for increased strategic autonomy in Europe," by the generics industry trade group Medicines for Europe, and "a major step forward towards more systematic collaborative procurement of cancer treatments," by the Association of European Cancer Leagues (ECL). Meanwhile, EFPIA, which represents the research-based pharmaceutical industry, said the act "needs to go further and provide an effective response to fragmented national contingency stock requirements that disrupt the functionality of the single market."... Global Sub. Full

Geopolitics Complicates Europe's Push for Pharma Autonomy

(3/13, Sarantis Michalopoulos, Vasiliki Angouridi and Emma Pirnay, Euractiv) ...Dr Aris Angelis, general secretary of the Greek Health Ministry, who participated in an alliance working group, told Euractiv that understanding a country's ability to produce key pharmaceutical components - such as active ingredients and finished medicines - helps assess its potential for partnerships. "To strengthen Europe's pharmaceutical supply chains, 18 key criteria have been identified at the macro-level, grouped into four categories: production capacity, ease of trade, third-country policy, and geopolitical factors", Dr Angelis said... Sub. Req’d

US Tariffs On Indian Pharma Will Be Hard to Implement & Inflationary: Systematix's Vishal Manchanda

(3/13, Mangalam Maloo and Nigel D'Souza, CNBC TV-18) ...The United States may find it difficult to impose tariffs on Indian pharmaceutical products as it would likely drive up costs and contribute to inflation, according to Vishal Manchanda, Pharma Analyst at Systematix Group...Furthermore, he stated that the US lacks the infrastructure to produce these drugs domestically at scale, making it unlikely for tariffs to be implemented effectively. Meanwhile, Sun Pharmaceutical Industries stands to gain significantly from its recent acquisition of Checkpoint Therapeutics, which gives it access to the PD-L1 inhibitor, cosibelimab. This drug, used for treating skin cancer, represents a large market opportunity... Full

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