Wednesday, April 10, 2024

Biosimilar Uptake Appears to Finally Be On the Upswing, and Biocon Biologics is Betting On the Sector's Future

(4/9, Michael Gibney, PharmaVoice) ..."The real risk around this is when you have all the approvals and then things still don't move. I can have the product and all the programs and launch with FDA approval, but I'm still fighting for 2%," said Matthew Erick, chief commercial officer at Biocon Biologics. "We need to think about a ‘biosimilar first' program for adoption, because if biosimilars come in and the innovator just lowers their price, like you saw with Humira, and biosimilars gain zero traction, that's not good for the future because a lot of money was spent on those biosimilars," Erick said. "We need to [ensure] biosimilars are supported as a viable entity not to take the branded people out but … continuing to introduce competition."... Full

Dr Reddy's Promotes Drug Access With Three Branded Deals In India

(4/9, Urte Fultinaviciute, Generics Bulletin) ...Over the past few weeks, Dr Reddy's shook hands with three pharma companies – Bayer, Sanofi, and Pharmazz – allowing the Indian generics firm to market or distribute multiple branded products in a bid to address unmet patient needs in India...Commenting on the deal, Dr Reddy's CEO of branded markets (India and emerging markets) MV Ramana said that strengthening the chronic therapy portfolio in India continues to be a focus area for the firm... Global Sub. Full

Pfizer Plots Abrysvo Expansion with Positive Study in Wide Pool of Adults at Risk from RSV

(4/9, Fraiser Kansteiner, Fierce Pharma) ...Pfizer has unveiled positive top-line immunogenicity and safety results from the phase 3 MONeT trial testing Abrysvo in adults ages 18 to 59 at risk of developing severe RSV-associated lower respiratory tract disease. With the trial win in hand, Pfizer says it plans to submit the data to regulatory agencies and request an expansion of the shot's current indication to include people ages 18 and up, according to a Tuesday press release... Full

Lupin Launches Generic Formulation of Bacterial Pneumonia Drug in United States

(4/10, Financial Express) ...Global pharma major Lupin Limited on Wednesday announced the launch of the first generic version of Oracea (Doxycycline Capsules, 40 mg), in the United States. The launch comes after getting approval from the United States Food and Drug Administration... Full

Sun Pharma Halts Trial of its Parkinson's Disease Drug as it Fails to Show "Treatment Benefits"

(4/10, Sushmita Panda, Financial Express) ...Sun Pharma Advanced Research Company Ltd. (SPARC) on Wednesday announced that it is abandoning the Phase 2 study on Vodobatinib for Parkinson's Disease. According to the company's exchange filing, the study "failed to demonstrate superiority of Vodobatinib" as compared to placebo. The decision was based on the results of interim analysis from the PROSEEK study, a global, randomised, double-blind, placebo-controlled Phase 2 study in patients with Early Parkinson's Disease... Full

Drugmaker Stada Said to Talk to Buyout Firms in €8 Billion Sale

(4/9, Eyk Henning, Dinesh Nair, Swetha Gopinath and Michelle F. Davis, Bloomberg) ...Stada Arzneimittel AG has begun talking to potential buyers as the German generic-drug maker's owners pursue a possible sale that could value the company at about €8 billion ($8.7 billion), people with knowledge of the matter said...While the owners initially aimed for a valuation of about €10 billion, some would-be buyers say a price tag of more than €8 billion, or 10 times earnings, is more realistic... Full

Novartis to Cut 680 Jobs in Product Development

(4/9, John Revill, Reuters) ...Around 440 jobs will go in Switzerland and up to 240 in the United States over the next two to three years, the Basel-based company said. The job eliminations are separate from a restructuring programme which could lead up to 8,000 of Novartis's 78,000 global workforce being cut, it said...Meanwhile, the company said it would add roles over the next two to three years, meaning there will be a net reduction overall of 1-2% at a global level. Novartis said the changes were designed to reshape its capabilities to access local talent such as data scientists and regulation specialists in Britain... Full

Lupin, Glenmark and Natco Pharma Recall Drugs in US Market Due to Manufacturing Issues

(4/10, Financial Express) ...As per the latest Enforcement Report by the US Food and Drug Administration, Lupin is recalling 26,352 bottles of Rifampin Capsules (300 mg), an antibiotic medication in the US market...USFDA stated that Glenmark is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules due to "Failed Dissolution Specifications'...Hyderabad-based Natco Pharma is recalling 30 bottles of Lansoprazole delayed-release capsules, used to treat heartburn, in the American market, due to "CGMP Deviations", USFDA stated... Full

FDA Slams Jubilant Generics, Canada's Contract Pharmaceuticals with Form 483s

(4/9, Joseph Keenan, Fierce Pharma) ...Inspectors found the facility failed to investigate and identify the root cause of the presence of out-of-specification drugs in a batch of unspecified drugs that were later distributed in the U.S. after they were found in swab samples taken during a cleaning verification process, the FDA said. Additionally, the site's quality control unit was cited for not keeping proper records or following written procedures after an inspector "observed the presence of at least three uncontrolled investigation documents in a locked bin that were placed for shredding."... Full

Indian Pharma Receives FDA Warning Letter for Barefoot Employees and General 'Disrepair'

(4/9, Anna Brown, Endpoints News) ...The facility was in a state of "disrepair," according to the warning letter, with the FDA inspectors noting peeling paint, stains and residues. The agency found via interviews with microbiology lab employees that the company was making up or changing results for samples that didn't meet proper requirements. Further, employees operated manufacturing equipment without goggles, leaned over open eye drop bottles and failed to disinfect components that touched the facility walls... Full

Hydrocodone Shortage Leaves Many in Pain as Pharmacies Deal with Strict Regulations

(4/9, Amy Lange and David Komer, FOX 2 Detroit) ..."It's more like a liability issue - there's a shortage because basically everything's getting regulated - lots of pharmacies and warehouses got sued for dispensing opioids," said Rudy Najm, I Pharmacy. Pharmacist Rudy Najm owns the independent i Pharmacy in Livonia, and points to recent lawsuits against major chains like CVS and Rite Aid - a nationwide crackdown on opioids following the massive lawsuit against Purdue Oharma over oxycontin... Full

Parents Push for Reform After Son Couldn't Afford New Cost of Meds, Died of Asthma Attack

(4/9, Arman Rahman, FOX 47) ...Cole could always manage his asthma with his rescue inhaler, and Advair Diskus, which was always around $5. But days before his death when he tried to refill his Advair prescription at a Walgreens in Appleton, he was told it now cost about $539...They learned the pharmacy benefit manager, or PBM, for Cole's insurance, Optum RX, moved Advair to a different tier in his plan...A spokesperson for Optum RX said Advair was not covered on formulary when Cole went to refill it...Optum Rx said they never received a call from that Walgreens following the visit... Full

Did You Say 486%? Why One Company Thinks Such a Price Hike for its Drug is Justified

(4/10, Ed Silverman, STAT Plus) ...In explaining the move, Harrow chief executive officer Mark Baum has described the price hike as "reasonable," because Triesence is "extremely challenging" and "tricky" to manufacture. He maintained the company has incurred "tens of millions of dollars" in production and regulatory costs that must be recouped in order to bring the manufacturing process up to standards. And he cited inflation... Sub. Req'd

Analysis: PBM Resistance Led To $6B In Missed Biosimilar Savings

(4/9, Gabrielle Wanneh, InsideHealthPolicy) ...Although pharmacy benefit managers say they are supportive of efforts to increase the availability and use of biosimilar alternatives to common high-cost prescription drugs, the Association for Accessible Medicines' Biosimilars Council released a new analysis showing that health plans and patients have missed out on up to $6 billion in savings related to biosimilars for the blockbuster drug Humira due to rebate schemes by PBMs... Sub. Req'd

Desperate Times Cue Drug Middlemen's Loathsome Measures

(4/9, Steven Anderson, Chain Drug Review) ...Estimates project that prescription drug middlemen – pharmacy benefit managers – more than doubled their revenue over the course of the last decade and will do so again in the current decade. For example, Fortune Business Insights projects PBM revenues of more than $800 billion by 2030, and Grand View Research projects more than $900 billion... Full

Niche Medicare Plans for Poor, Unhealthy at Risk Under New Rule

(4/10, Tony Pugh, Bloomberg Law) ...A trade group representing safety net plans says lower MA payments could force some D-SNPs to reduce supplemental benefits for enrollees next year. Others may have to shrink their list of covered prescription drugs or increase enrollees' out-of-pocket costs, said one industry watcher. After enrollment in D-SNPs grew nearly 20% from 2023 to 2024, the new rates could imperil some plans' ability to provide coverage... Sub. Req'd

Medicare Drug Price Negotiations: Policy Implications Of The First 10 Drugs' Features

(4/9, Nitzan Arad Grace Hoover Richard Evans Mark B. McClellan, Health Affairs) ...In this article, we describe how CMS's approach to implementing the negotiations will be shaped by the distinctive features of the selected drugs in this first round. We make recommendations to CMS in the hope of advancing the program's predictability and reliability while minimizing the risk of unintended consequences. This is particularly important for encouraging investment in comparative effectiveness evidence relevant to Medicare beneficiaries, and potentially in new drugs and drug categories... Full

Xtandi Pricing and Patents: Alternatives To March-In Urged To Lower Medicare, Medicaid Costs

(4/9, Cathy Kelly, Pink Sheet) ...Now that a march-in request for Xtandi has failed again, advocates are pushing alternatives that could accelerate the launch of generic enzalutamide in federal programs. Twenty years ago, one of the provisions was used by the George W. Bush Administration to secure a 50% reduction in the price of Bayer's Cipro as a safeguard against anthrax attacks. With the prospect of a new, and potentially less sympathetic administration coming to Washington, advocates for Xtandi pricing relief may worry their options are running out... Sub. Req'd

CVS Caremark Says Court Botched Drug Price Math in Fraud Case

(4/9, Daniel Seiden, Bloomberg Law) ...On March 25, Judge Mitchell S. Goldberg of the U.S. District Court for the Eastern District of Pennsylvania granted partial summary judgment to Behnke on the issue of falsity under the FCA. But the court's ruling that price reporting was inaccurate is based on "erroneous mathematical assumptions," CVS said in its motion for reconsideration filed Monday. Correcting for the flawed assumptions shows that the record is unclear as to whether CVS set higher prices for Part D drugs and lower prices for commercial drugs, CVS said... Sub. Req'd

The IRA Is Already Curtailing Small Molecule Drug Development. Here's How to Reverse That.

(4/10, John Stanford, BioSpace) ...The Ensuring Pathways to Innovative Cures (EPIC) Act would give small molecule drugs the same 13 years of exemption from Medicare price negotiations that biologics receive, equalizing investment incentives for both classes at a manageable level. The EPIC Act would ensure that, whether small molecule or biologic, the most promising candidates will receive the same enthusiasm from investors. Lawmakers should move quickly to pass the bill... Full

The Pros and Cons of MA's Biosimilar Rule, Per 1 Pharmacist Group

(4/9, Mariah Taylor, Becker's Hospital Review) ...The biosimilar substitution rule would apply to all enrollees, including those taking the reference product prior to the effective date of change. The update is consistent with requests from ASHP to encourage biosimilar adoption. However, "State legislatures will need to move quickly to empower pharmacists to implement substitutions of lower-cost biosimilar products in order to avoid dramatic increases in patient cost sharing from this Medicare policy," Tom Kraus, ASHP vice president of government relations... Full

Drug Shortages: Study Examines Pandemic Supply Chain, HHS Proposes Resilience Incentive

(4/9, Joanne S. Eglovitch, Regulatory Focus) ...While drug shortages worsened due to supply chain issues at the start of the COVID-19 pandemic, they quickly returned to pre-pandemic levels, according to research published on April 5, in JAMA. The study also found that one in seven supply chain issue reports, or 14%, were associated with drug shortages... Full

Novartis, Sanofi and PhRMA Push FDA On How to Better Handle Complex Trial Designs

(4/9, Lia DeGroot, Endpoints News) ...Several industry stakeholders are asking the FDA to streamline its processes for working with sponsors on complex and innovative designs for clinical trials. The comments seek more clarity on how the FDA decides whether to accept designs, following a workshop on the topic last month...In its eight pages of comments submitted last Friday, PhRMA said that it supports continuing to offer complex innovative design meetings beyond the pilot and that the FDA should prioritize "consistency and predictability" in how it handles the meetings... Full

Virginia Governor Vetoes Plans to Create a Prescription Drug Affordability Board

(4/9, Ed Silverman, STAT Plus) ...Virginia Gov. Glenn Youngkin vetoed legislation late Monday that would have established an advisory board to better manage the state's prescription drug costs...Youngkin said he vetoed the bill because the legislation didn't take individual patients' needs into consideration...But PhRMA welcomed the veto, saying in a statement to Endpoints News that PBMs and insurance companies are driving up drug costs... Sub. Req'd

Generic Medicines: 70% of Dispensed Medicines and Critical to Healthcare

(4/10, Medicines for Europe) ...Speaking at the launch of the IQVIA ‘Beneath the Surface' report, the Chair of Medicines for Europe's Generic medicines Market Access Committee, Arnaud Maheas, said: "European healthcare systems rely on generic medicines to deliver public health Generic medicines policies should look beyond cost-savings to empower our industry to deliver the long-term and largely unappreciated benefits described in the IQVIA report. Ongoing downward pressure on prices, as in Germany where generic medicines cover 80% of volume at just 7% of the cost, is a direct cause of industry-wide supply chain challenges. EU authorities and national governments need to incorporate security of supply for public health alongside savings when designing generic medicine policies."... Full

Industry Must Be Incentivized To ‘Play Ball' On Implementation Studies

(4/9, Eliza Slawther, Pink Sheet) ...In oncology, there is a critical need for research that focuses on implementation science and how medicines are used in routine practice, but low levels of investment in these types of trials both from industry and research funding organizations is a problem. This was the message delivered at a European workshop on medicines optimization by Richard Sullivan, professor of cancer policy and global health at Kings College London and director of the Kings Institute of Cancer Policy... Sub. Req'd

Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients

(4/9, Skylar Jeremias, The Center For Biosimilars) ...Data from 2021 and 2022 showed that biosimilar use within an Italian health care company was on the rise, suggesting that the country could achieve total utilization in the coming years. The researchers touted the growing success, saying that more use will benefit the National Health System and citizens who rely on an efficient and sustainable health care policy... Full

Delhi High Court Seeks Response from Govt, NPPA On Glenmark's Plea

(4/9, Indu Bhan, The Economic Times) ...Glenmark Pharma on Tuesday moved the Delhi High Court, seeking setting aside the National Pharmaceutical Pricing Authority's standing order that fixed a lower retail price than the launched price of its anti-diabetic drug formulations comprising Remogliflozin + Vidagliptin + Metmformin... Full

Steady US Sales to Bring a Healthy Quarter for Pharma Sector

(4/10, Neethi Rojan, Money Control) ...Moderating pricing pressures complemented by increased traction in limited-competition generic products such as Revlimid and Spiriva is likely to strengthen YoY growth of the US generics segment. Growth in these companies will be led by niche launches (g-Spiriva and other key products for Lupin/g-Revlimid and other launches for Dr. Reddy's Laboratories/new launches for Alembic Pharma)... Full

Relief for Pharma Companies as API Prices See a Sharp Fall

(4/10, Teena Thacker, The Economic Times) ...India's pharmaceutical industry, which is dependent on China for APIs, intermediates and bulk drugs, had seen an exponential price increase during Covid times. The rise in API prices continued until early this year. However, things have started to change, people in the know told ET. "Prices have seen a sharp decrease in the last two months. The demand for APIs has gone down, too," confirmed Mehul Shah, who tracks the Chinese pharmaceutical industry... Full

Boehringer Ingelheim Upbeat On China, Forms Cancer Drug Partnership

(4/9, Russell Flannery, Forbes) ...Boehringer Ingelheim, one of the world's largest pharmaceutical companies, announced a new partnership in China on Monday, and remains upbeat about the market amid strains between Beijing and the country's leading trade partners. Sino Biopharmaceutical, the Beijing-headquartered drug maker whose founding chairman is billionaire Tse Ping, and Boehringer Ingelheim of Germany will team up to develop and commercialize cancer drugs, the two companies said... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.