Chetan Pujara

It is essential that we are more efficient in biosimilar development, and indeed this is an FDA BsUFA III Priority. The science is asked and answered for reducing/eliminating clinical studies as well as for a global comparator product (the brand used as reference is already global so a biosimilar to it should be too).  #biologics #biosimilars #biotech #regulatoryreliance #accessmatters #accessforall #HealthForAll #InnovatingAccess #PassionForHealth

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#ManufacturingNews: Sanofi is looking to bulk up its workforce at its global capacity center in Hyderabad, India, with a multi-year investment totaling 400 million euros ($437 million), according to reports. The investment will stretch through the end of the decade, with the first chunk of 100 million euros ($109 million) coming by next year, The Hindu reports. The facility currently employs around 1,000 people, according to reports. By growing to 2,600-strong over the next two years, the site stands to become the largest of #Sanofi’s four global capacity hubs, Sanofi's executive vice president of business operations, Madeleine Roach, said at a press conference, according to The Deccan Herald. The company's four global capacity centres are located in Budapest, Hungary, Bogota, Columbia, Kuala Lumpur, Malaysia and Hyderabad. In India, the company is “resetting the footprint” and leveling up its “value accretive activities,” chief digital officer Emmanuel Frenehard noted, according to the Financial Express. The expansion will grow the site’s digital team and utilize #artificialintelligence tools. Read more from Fierce Pharma 👇🏼

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#Biotechnology contract manufacturing has witnessed exponential growth, now an integral component of the global biotech ecosystem. Priyanka Bhendale of MarketsandMarkets™ takes a deeper look. #contractmanufacturing #biosimilars

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Elaine Chen at STAT notes Eli Lilly and Company raised its full-year guidance on Tuesday while it reported strong first-quarter sales of Zepbound, beating the predicted $2.39, up to $2.58 per share. Zepbound, brought in $517 million in sales in the first quarter of this year, up from $389 million that analysts expected. Its sister diabetes drug Mounjaro posted $1.8 billion in sales. Anat A., Lilly’s chief financial officer, said ‘…Now that we’re four months into the year, we have greater visibility into these nodes of capacity and feel more confident…’ in terms of their supply chains. In addition, Eli Lilly has FDA approval to sell the drugs in vials, in addition to the single-dose injectable pens, which can help speed up the manufacturing process. In the UK and Europe, a multi-dose injectable ‘Kwikpen’ is also approved. In addition, Daniel Skovronsky, Lilly’s chief scientific officer, noted their small molecule oral GLP-2 drug, orforglipron, is more complicated and time-consuming than making other small molecule drugs. Wow – a ton of updates both financially and clinically too. https://lnkd.in/eAd7Tn7X

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In the pharmaceutical industry, the conversation around manufacturing challenges is ongoing. A critical issue that always stands out is the environmental impact of our operations, highlighted by severe contamination in places like Hyderabad and Bonthapalle. These situations raise significant questions about our responsibilities beyond compliance—about our ethical obligations to communities and ecosystems. As someone deeply embedded in this industry, it prompts me to think about the collective actions we can take to mitigate these impacts. How can we, as an industry, better align our pursuit of medical advancements with our environmental responsibilities? Let’s share our experiences and push for meaningful, industry-wide change. #Pharmaceuticals #Sustainability #EnvironmentalImpact #HealthcareInnovation

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When considering drugs for approval, the FDA should… Evaluate clinically meaningful outcomes rather than rely on surrogate outcomes. Restrict accelerated approval only to drugs that represent innovative treatment approaches or that have demonstrated robust clinical benefits. Withdraw market authorization for all drugs approved through the accelerated approval process that do not go on to meet pre-specified clinical effectiveness endpoints in post-marketing studies. The FDA should, but it often doesn’t. Stop depending on the FDA. As an employer you need to implement a system to independently assess the clinical benefits of drugs. #evidencebasedmedicine #valuebasedhealthcare #employeebenefits

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📢 FDA has released a revised draft guidance for biologics companies regarding promotional communications for prescription biologics. The draft guidance covers reference products, biosimilars, and interchangeable biosimilars. Titled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers," the guidance provides considerations for presenting accurate and non-misleading data and information in promotional communications. This revised draft guidance replaces the 2020 draft guidance and includes additional recommendations, an example of an interchangeable biosimilar product, and clarifying editorial changes. FDA remains committed to supporting the adoption of biosimilars and identifying false or misleading statements about biologics. Remember, biosimilars and interchangeable biosimilars are as safe and effective as their reference product. Read more about the draft guidance here: [insert link to FDA website]

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📨 Potential implications exist in regard to #LCM and #strategies regarding market exclusivity, see below, the latest from the FTC, sending warning letters to ten major pharma companies in an attempt to continue challenging and cracking down on #JunkPatents. 📂 The claims are around 'inaccurate or improper' patents in place which essentially block competition and keep drug prices high. Many big-name prescription brands are included in this round of probes. 2️⃣ 0️⃣ : "The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate." 🤔 Are your brands affected? ❓ How might actions against you or your competitors affect your LCM strategy? https://lnkd.in/eVuapvWJ #LifeCycleManagement #RegulatoryAffairs #Policy #FTC #FederalTradeCommission #OrangeBook #PharmaPatents #AntiTrust #Pharma

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Hello Everyone, I will be delivering the first of these sessions on 29th Apr. Through practical examples, I will be sharing my knowledge and experience on how compliance & quality management go hand in hand to achieve operational excellence. #pharmaceuticalmanufacturing #medicaldevices #biotech #clinicaltrials #GMP #compliance #qualityassurance #qualitymanagement

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Situationships: What They Are and 5 Signs You’re in One : “Situationship” isn’t a word you’ll find in the dictionary, but it’s hard to avoid in popular culture. So, what is it exactly? According to psychologist Dr. Susan Albers, a situationship is a romantic relationship that hasn’t been formalized. “Situationships are characterized by a lack of obligation or exclusivity, but the real hallmark is a lack of clear boundaries or labels,” she explains. “There are elements of friendship and romance, but they exist without defining the relationship. So, essentially, you have many of the benefits of a traditional relationship without having to make a commitment.” As you can imagine, this kind of attachment has upsides and downsides. One the one hand, situationships may allow you to feel the sense of connection you’d experience in a standard-issue relationship and the independence that comes with being single. On the other hand, if you’re not clear on the nature of your involvement, it can’t progress. It’s difficult to maintain, emotionally. For further reading :

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💲 Neuroscience biotech LB Pharmaceuticals, Inc. is prepping for an IPO...as the antipsychotics #competitive space ramps up its developments. ❔ What is LB's differentiator? From Endpoints News: 💊 "LB is in mid-stage testing with an #oral treatment candidate for #schizophrenia. Named 'LB-102', the company has described it as a new and improved version of the decades-old medicine amisulpride, a D2 and D3 antagonist that has been sold in many countries but never approved in the US as an antipsychotic. LB has previously said it expects to run multiple Phase 3 trials in 2025 and ask for FDA approval in 2028. It could also test the drug candidate in patients with depression, bipolar depression and other indications." #Antipsychotics #MDD #Schizophrenia #IPO #BipolarDisorder #Biotech #RegulatoryAffairs #Pharma #Healthcare

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It was a remarkable positive experience to speak and meet industry entrepreneurs & leaders from the Pharma world at the CPHI North America event held recently in May 2024 at the Pennsylvania Convention Center in the heart of Philadelphia. The topic I researched and spoke about, “Difficulties Meeting US FDA Regulatory Requirements,” was complex and much discussed in the industry. Due to its vastness, the topic was divided into three parts to ensure a comprehensive understanding. Part 1: Changes in the Pharmaceutical CGMP Part 2: Trends. The Rising US FDA Observation Frequencies Part 3: Challenges and Mitigation  #usfda #eugmp #CGMP #compliance #pharmaceuticalindustry #drugmanufacturing #biotechnology #cellandgenetherapy #qualityassurance #qualitymanagementsystems #alcoa #dataintegrity #cgmpcompliance #CPHI

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In this conversation with Vas Narasimhan, we get well into the science behind the latest results for Scemblix at ASCO and remibrutinib at EEACI: why does Novartis believe these position Scemblix for frontline in CML, what's the landscape for remi in urticaria, how do these position NVS towards its growth goal? Dig in - come for the science, stay for the strategy. A Special Episode of The BioCentury Show

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An important update on the #BiosecuresAct, which includes a grandfather clause on existing contracts thru 2032, but this new draft prohibits setting up new agreements or extending existing ones. While balancing national security, also to ponder is "the potential fallout could have negative impacts on the supply chains of several drugmakers." https://lnkd.in/ebcE6x4w #Policy #Biotech #Innovation #GovernmentalAffairs #Pharma #Healthcare

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This was one of the collaborative events that I attended this year and the quote by “Helen Keller” kept ringing in my years:  "Alone we can do so little; together we can do so much." In the annals of history, it is well documented how modern humans, through COLLABORATION, outsmarted the existing hominoid, who had 20-30% more grey matter in the skull and had been native to the territory. We “Homo sapiens” were adept at sharing knowledge, resources, and cooperating in large groups, which may have given us an advantage in adapting to changing environments. This collaborative capability enabled us to innovate more rapidly, develop more efficient hunting techniques, and adapt to diverse ecological niches. In contrast, Neanderthals, though also capable of complex behaviours and tool-making, couldn’t match us-Homo sapiens in the extent or efficiency of our collaborative efforts. The outcome is known to everyone. In the book, "Innovator's Dilemma", Clayton Christensen elucidates how disruptive technologies can upend established industries by leveraging collaborative efforts in innovative ways. As disruptive technologies mature and improve, they eventually reach a point where they can compete directly with established products, often surpassing them in performance and capturing larger portions of the market. This process of disruptive innovation, driven by a collaborative effort and a focus on incremental improvements, allows new technologies to outsmart existing competition despite starting from a position of apparent weakness. So even in the space of niche technology collaboration would be needed to outwin your competitors. Albert Einstein quoted in multiple events: "We cannot solve our problems with the same thinking we used when we created them”. Through such collaborative efforts, we learn from each other and get the directional pathways. My heartfelt thanks to Express Pharma for creating a culture of sharing through such wonderful events. It was a pleasure to interact with the doyens of the industry and get enlightened. Wonderful feeling!

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Supreme Court rejects controversial Purdue Pharma bankruptcy deal https://lnkd.in/gHrGg8tY For those of us working in #HCVElimination and #EndTheEpidemics and generally working to support #HarmReduction measures this was a case we've been following with mixed feelings. The court's 5-4 ruling shuts down the legal shield that the Sacklers set up with Perdue's #OpiodSettlement lawsuit. On one hand the landmark settlement of Billions of dolllars, would be helping solve the myriad of problems created in-part by the Sacklers. On the other hand, it would let them walk away from enabling what many would consider murder and destruction of hundreds of thousands of people and their families. For those who are familiar with the Sacklers and their long history here, #Opiods were not the family's first foray here, this was decades of work by a family who has sought to enrich themselves at the cost of American lives by creating an Empire of #Pain. (If you're not familiar with just how deep the Sacklers have been involved with this whole problem highly recommend reading #EmpireOfPain by Patrick Radden Keefe. it goes into serious depth of the more than half-century this family has been involved with #PainManagement in the United States and the methods of their manipulation of doctors, regulators, and patients.) This also will have reverberations regarding how companies will be able to use #Bankruptcy to avoid responsibility for things they could have forseen. The ramifications of each wave of the opioid epidemic, have left in their wake millions of people not only impacted by the OD deaths, the financial and emotional destruction of families but also by the viral epidemics spread, adding a legacy so costly in every sense, that the multi-billion dollar settlement was in many senses a pittance compared to the decades of damage dealt to the American People and their families. It may take years for a new settlement to be reached, but in the meantime, the settlement money from the other lawsuits will likely be spent, hopefully to help these communities and families. Hopefully this isn't Tobacco Settlements all over again (tons of misspent money) For now the legacy remains a syndemic: #HepC #HIV #HBV #HepatitisC #HepB

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Both Biocon and partners Samsung Bioepis/Biogen have reason to cheer: The FDA approved their respective #aflibercept #biosimilars, Yesafili™ (aflibercept-yszy) and Opuviz™ (aflibercept-jbvf) on May 20. The FDA approved both as #interchangeable biosimilars, which further confuses the issue of biosimilar interchangeability, both in terms of exclusivity and applicability. #Eylea #Regeneron #ranibizumab #Xbrane #Xlucane #Yesafili #Opuviz Amgen Celltrion Inc Formycon AG https://wp.me/p7gt6c-7uS

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Concerns arise regarding gaps in education and communication from biosimilar manufacturers, emphasizing the necessity of comprehensive support programs and clear communication channels. Patient access to biosimilars is seen as crucial, with biosimilar adoption programs needing to address various factors such as coverage, support systems, and pharmacoeconomic considerations. Biosimilar Red Tape Elimination Act removes the requirement for switching studies. Eliminating this barrier increases access to lower cost biosimilars and has potential to save payers and consumers billions of dollars. To date, only few biosimilars have been granted interchangeability status.

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Great article summarizing a fascinating and very timely #MedPAC conversation last week. If nothing else, the article puts some of FDA's proposals around #biosimilars and #interchangable #biosimilars into context and reinforces how complex #drugpricing policy really is. One grim reality for many #raredisease patients: list prices have little correlation with actual #out-of-pocket costs for our patients, many of whom rely on #medicalproducts on #specialtytiers of the formularies. For background, MedPac is the #Medicare Payment Advisory Commission, an independent legislative branch set up to advise #Congress on the Centers for Medicare & Medicaid Services #Medicare program, and a key voice in the #drugpricing and #pbm #pharmacybenefitmanager reform debates.

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